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Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

If we’ve learned anything about obesity prevention it’s that if we wait too long the die is cast and our success rate is nil. The GLP-1 antagonists seem to be a workable solution for treating the adult and adolescent population, but I have been afraid that their success will divert too much of our attention away from prevention.

Fortunately, there still seems to be a few researchers committed to the age group in which obesity could be headed off before our only option is treatment. In one recent study, “Neighborhood Food Access in Early Life and Trajectories of Child Body Mass Index and Obesity,” researchers collected data from more than 28,000 children in 55 cohorts during the period from 1994 to 2023). The investigators found that residence in a low–food access, low-income neighborhoods during pregnancy and early childhood was associated with higher BMI “Z” scores, a higher risk of obesity, and severe obesity in childhood. The researchers defined low food access as living greater than 0.5 miles away from a grocery store in an urban setting or greater than 10 minutes away in a rural setting. I don’t think those associations should surprise us, but having some data from a large population may be valuable should we ever find the political will to undertake any steps toward prevention.

I found a Viewpoint article published 2 weeks earlier in the same journal, titled, “The Exposome as a Key to Understanding Pediatric Health Disparities.” I know what the “biome” is and have heard gastroenterologists expound on the power that billions of our little single-celled friends residing in our gut have on seemingly unrelated and spatially distant events in our body. But, “exposome” was a new word for me, although it turns out the concept is simple and one I had harbored since late childhood. 

 

The opening sentence of the article reads “One’s environment profoundly changes health outcomes throughout one’s lifespan.” That truism was obvious to my 7-year-old self as I observed my playmates who lived in a poorly kept house in the less desirable area two blocks away and didn’t eat breakfast and were sick more often than the rest of us more-fortunates.

The authors define the exposome as the “totality of an individual’s non-genetic exposures, including psychosocial experiences, structural social determinants, chemical pollution, and neighborhood infrastructure.” This seems to be a pretty complete description of the nurture side of the nature versus nurture conversation. 

I suspect that, like me, most of you through observation and intuition have included your own interpretation of the exposome in your professional activities. However, the authors feel we could be more robust in our efforts and claim that “current pediatric practice largely neglects to characterize health disparities in terms of salient environmental practices.” They go on to call for incorporation of an “exposome lens in pediatric research and healthcare delivery.”

I’m not sure this is a valid criticism. There is certainly more that could be done when it comes to research that examines the effect of environmental stressors. And, I suspect the authors would view this recent paper on the association between neighborhood food access as a step in the right direction. However, when it comes to healthcare delivery, at least at the level where the stethoscope meets the chest, I think, or at least hope, the authors are underestimating the observational skills and sensitivity of primary care providers.

We were all taught to take an appropriate medical history when evaluating a patient. And, through our formal education, our personal observations and through exposure to papers like this one on food access we must be aware of the effect of environmental stressors on our patients’ health. Is there more we could learn about those kind of associations? Certainly. This is where a more broadly focused exposome lens could be most effective. 

The authors of the article observed: “The effect of the exposome is not uniform for all individuals but rather intersects across identities precipitating unique outcomes.” The practical reality is that to generate statistically significant data research must look at identities. This doesn’t mean that large population studies are without value. However, it does obligate investigators to include that caveat about the uniqueness of the individual in their conclusions. And, it is our duty as providers to keep this reality in mind as we interpret studies we read in the context of each individual patient. 

When it comes to healthcare delivery at the structural level, I am concerned that we are moving in a direction that is making it more difficult for the provider to become familiar with the patient’s exposome. I am talking about an over-reliance on the team care delivery model that too often results in the “We never/seldom see the same provider” patient complaint.

I don’t care how slick and user-friendly a practice’s EHR system is; the best way to learn about a patient’s exposome is by repeated exposure (pun unintended) to the same provider. This isn’t always possible, and a well-crafted and conscientiously managed EHR can fill in some of the gaps. But, it is a distant second best. 

Awareness of the importance of the exposome is only the starting point. Finding the political will to make the changes necessary to improve our patients’ outcomes is the bigger challenge. Grocery stores well-stocked with healthy foods don’t just pop up where we want them because we think they may hold answer to preventing pediatric obesity.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

If we’ve learned anything about obesity prevention it’s that if we wait too long the die is cast and our success rate is nil. The GLP-1 antagonists seem to be a workable solution for treating the adult and adolescent population, but I have been afraid that their success will divert too much of our attention away from prevention.

Fortunately, there still seems to be a few researchers committed to the age group in which obesity could be headed off before our only option is treatment. In one recent study, “Neighborhood Food Access in Early Life and Trajectories of Child Body Mass Index and Obesity,” researchers collected data from more than 28,000 children in 55 cohorts during the period from 1994 to 2023). The investigators found that residence in a low–food access, low-income neighborhoods during pregnancy and early childhood was associated with higher BMI “Z” scores, a higher risk of obesity, and severe obesity in childhood. The researchers defined low food access as living greater than 0.5 miles away from a grocery store in an urban setting or greater than 10 minutes away in a rural setting. I don’t think those associations should surprise us, but having some data from a large population may be valuable should we ever find the political will to undertake any steps toward prevention.

I found a Viewpoint article published 2 weeks earlier in the same journal, titled, “The Exposome as a Key to Understanding Pediatric Health Disparities.” I know what the “biome” is and have heard gastroenterologists expound on the power that billions of our little single-celled friends residing in our gut have on seemingly unrelated and spatially distant events in our body. But, “exposome” was a new word for me, although it turns out the concept is simple and one I had harbored since late childhood. 

 

The opening sentence of the article reads “One’s environment profoundly changes health outcomes throughout one’s lifespan.” That truism was obvious to my 7-year-old self as I observed my playmates who lived in a poorly kept house in the less desirable area two blocks away and didn’t eat breakfast and were sick more often than the rest of us more-fortunates.

The authors define the exposome as the “totality of an individual’s non-genetic exposures, including psychosocial experiences, structural social determinants, chemical pollution, and neighborhood infrastructure.” This seems to be a pretty complete description of the nurture side of the nature versus nurture conversation. 

I suspect that, like me, most of you through observation and intuition have included your own interpretation of the exposome in your professional activities. However, the authors feel we could be more robust in our efforts and claim that “current pediatric practice largely neglects to characterize health disparities in terms of salient environmental practices.” They go on to call for incorporation of an “exposome lens in pediatric research and healthcare delivery.”

I’m not sure this is a valid criticism. There is certainly more that could be done when it comes to research that examines the effect of environmental stressors. And, I suspect the authors would view this recent paper on the association between neighborhood food access as a step in the right direction. However, when it comes to healthcare delivery, at least at the level where the stethoscope meets the chest, I think, or at least hope, the authors are underestimating the observational skills and sensitivity of primary care providers.

We were all taught to take an appropriate medical history when evaluating a patient. And, through our formal education, our personal observations and through exposure to papers like this one on food access we must be aware of the effect of environmental stressors on our patients’ health. Is there more we could learn about those kind of associations? Certainly. This is where a more broadly focused exposome lens could be most effective. 

The authors of the article observed: “The effect of the exposome is not uniform for all individuals but rather intersects across identities precipitating unique outcomes.” The practical reality is that to generate statistically significant data research must look at identities. This doesn’t mean that large population studies are without value. However, it does obligate investigators to include that caveat about the uniqueness of the individual in their conclusions. And, it is our duty as providers to keep this reality in mind as we interpret studies we read in the context of each individual patient. 

When it comes to healthcare delivery at the structural level, I am concerned that we are moving in a direction that is making it more difficult for the provider to become familiar with the patient’s exposome. I am talking about an over-reliance on the team care delivery model that too often results in the “We never/seldom see the same provider” patient complaint.

I don’t care how slick and user-friendly a practice’s EHR system is; the best way to learn about a patient’s exposome is by repeated exposure (pun unintended) to the same provider. This isn’t always possible, and a well-crafted and conscientiously managed EHR can fill in some of the gaps. But, it is a distant second best. 

Awareness of the importance of the exposome is only the starting point. Finding the political will to make the changes necessary to improve our patients’ outcomes is the bigger challenge. Grocery stores well-stocked with healthy foods don’t just pop up where we want them because we think they may hold answer to preventing pediatric obesity.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

If we’ve learned anything about obesity prevention it’s that if we wait too long the die is cast and our success rate is nil. The GLP-1 antagonists seem to be a workable solution for treating the adult and adolescent population, but I have been afraid that their success will divert too much of our attention away from prevention.

Fortunately, there still seems to be a few researchers committed to the age group in which obesity could be headed off before our only option is treatment. In one recent study, “Neighborhood Food Access in Early Life and Trajectories of Child Body Mass Index and Obesity,” researchers collected data from more than 28,000 children in 55 cohorts during the period from 1994 to 2023). The investigators found that residence in a low–food access, low-income neighborhoods during pregnancy and early childhood was associated with higher BMI “Z” scores, a higher risk of obesity, and severe obesity in childhood. The researchers defined low food access as living greater than 0.5 miles away from a grocery store in an urban setting or greater than 10 minutes away in a rural setting. I don’t think those associations should surprise us, but having some data from a large population may be valuable should we ever find the political will to undertake any steps toward prevention.

I found a Viewpoint article published 2 weeks earlier in the same journal, titled, “The Exposome as a Key to Understanding Pediatric Health Disparities.” I know what the “biome” is and have heard gastroenterologists expound on the power that billions of our little single-celled friends residing in our gut have on seemingly unrelated and spatially distant events in our body. But, “exposome” was a new word for me, although it turns out the concept is simple and one I had harbored since late childhood. 

 

The opening sentence of the article reads “One’s environment profoundly changes health outcomes throughout one’s lifespan.” That truism was obvious to my 7-year-old self as I observed my playmates who lived in a poorly kept house in the less desirable area two blocks away and didn’t eat breakfast and were sick more often than the rest of us more-fortunates.

The authors define the exposome as the “totality of an individual’s non-genetic exposures, including psychosocial experiences, structural social determinants, chemical pollution, and neighborhood infrastructure.” This seems to be a pretty complete description of the nurture side of the nature versus nurture conversation. 

I suspect that, like me, most of you through observation and intuition have included your own interpretation of the exposome in your professional activities. However, the authors feel we could be more robust in our efforts and claim that “current pediatric practice largely neglects to characterize health disparities in terms of salient environmental practices.” They go on to call for incorporation of an “exposome lens in pediatric research and healthcare delivery.”

I’m not sure this is a valid criticism. There is certainly more that could be done when it comes to research that examines the effect of environmental stressors. And, I suspect the authors would view this recent paper on the association between neighborhood food access as a step in the right direction. However, when it comes to healthcare delivery, at least at the level where the stethoscope meets the chest, I think, or at least hope, the authors are underestimating the observational skills and sensitivity of primary care providers.

We were all taught to take an appropriate medical history when evaluating a patient. And, through our formal education, our personal observations and through exposure to papers like this one on food access we must be aware of the effect of environmental stressors on our patients’ health. Is there more we could learn about those kind of associations? Certainly. This is where a more broadly focused exposome lens could be most effective. 

The authors of the article observed: “The effect of the exposome is not uniform for all individuals but rather intersects across identities precipitating unique outcomes.” The practical reality is that to generate statistically significant data research must look at identities. This doesn’t mean that large population studies are without value. However, it does obligate investigators to include that caveat about the uniqueness of the individual in their conclusions. And, it is our duty as providers to keep this reality in mind as we interpret studies we read in the context of each individual patient. 

When it comes to healthcare delivery at the structural level, I am concerned that we are moving in a direction that is making it more difficult for the provider to become familiar with the patient’s exposome. I am talking about an over-reliance on the team care delivery model that too often results in the “We never/seldom see the same provider” patient complaint.

I don’t care how slick and user-friendly a practice’s EHR system is; the best way to learn about a patient’s exposome is by repeated exposure (pun unintended) to the same provider. This isn’t always possible, and a well-crafted and conscientiously managed EHR can fill in some of the gaps. But, it is a distant second best. 

Awareness of the importance of the exposome is only the starting point. Finding the political will to make the changes necessary to improve our patients’ outcomes is the bigger challenge. Grocery stores well-stocked with healthy foods don’t just pop up where we want them because we think they may hold answer to preventing pediatric obesity.

 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

TOPLINE:

Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.

METHODOLOGY:

• Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
• More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
• Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
• Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
• The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.

TAKEAWAY:

• Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
• Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
• Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
• Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.

IN PRACTICE:

“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.

SOURCE:

The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.

DISCLOSURES:

This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.

METHODOLOGY:

• Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
• More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
• Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
• Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
• The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.

TAKEAWAY:

• Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
• Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
• Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
• Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.

IN PRACTICE:

“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.

SOURCE:

The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.

DISCLOSURES:

This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.

METHODOLOGY:

• Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
• More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
• Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
• Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
• The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.

TAKEAWAY:

• Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
• Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
• Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
• Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.

IN PRACTICE:

“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.

SOURCE:

The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.

DISCLOSURES:

This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Suicide and self-harm continue to be serious concerns in Europe, despite decreasing rates over the past two decades. In 2021 alone, 47,346 people died by suicide in the European Union, close to 1% of all deaths reported that year. Measures have been taken at population, subpopulation, and individual levels to prevent suicide and suicide attempts. But can more be done? Yes, according to experts.

Researchers are investigating factors that contribute to suicide at the individual level, as well as environmental and societal pressures that may increase risk. New predictive tools show promise in identifying individuals at high risk, and ongoing programs offer hope for early and ongoing interventions. Successful preventive strategies are multimodal, emphasizing the need for trained primary care and mental health professionals to work together to identify and support individuals at risk at every age and in all settings.

 

‘Radical Change’ Needed

The medical community’s approach to suicide prevention is all wrong, according to Igor Galynker, MD, PhD, clinical professor of psychiatry and director of the Mount Sinai Suicide Prevention Research Lab in New York City. 

Galynker is collaborating with colleagues in various parts of the world, including Europe, to validate the use of suicide crisis syndrome (SCS) as a diagnosis to help imminent suicide risk evaluation and treatment.

SCS is a negative cognitive-affective state associated with imminent suicidal behavior in those who are already at high risk for suicide. Galynker and his colleagues want to see SCS recognized and accepted as a suicide-specific diagnosis in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. 

Currently, he explained to this news organization, clinicians depend on a person at risk for suicide telling them that this is what they are feeling. This is “absurd,” he said, because people in this situation are in acute pain and distress and cannot answer accurately.

“It is the most lethal psychiatric condition, because people die from it ... yet we rely on people at the worst moment of their lives to tell us accurately when and how they are going to kill themselves. We don’t ask people with serious mental illness to diagnose their own mental illness and rely on that diagnosis.”

Data show that most people who attempt or die by suicide deny suicidal thoughts when assessed by healthcare providers using current questionnaires and scales. Thus, there needs to be “a radical change” in how patients at acute risk are assessed and treated to help “prevent suicides and avoid lost opportunities to intervene,” he said.

Galynker explained that SCS is the final and most acute stage of the “ narrative crisis model” of suicide, which reflects the progression of suicidal risk from chronic risk factors to imminent suicidal risk. “The narrative crisis model has four distinct and successive stages, with specific guidance and applicable interventions that enable patients to receive a stage-specific treatment.”

“Suicide crisis syndrome is a very treatable syndrome that rapidly resolves” with appropriate interventions, he said. “Once it is treated, the patient can engage with psychotherapy and other treatments.”

Galynker said he and his colleagues have had encouraging results with their studies so far on the subjective and objective views of clinicians using the risk assessment tools they are developing to assess suicidal ideation. Further studies are ongoing. 

 

Improving Prediction

There is definitely room for improvement in current approaches to suicide prevention, said Raffaella Calati, PhD, assistant professor of clinical psychology at the University of Milano-Bicocca, Italy, who has had research collaborations with Galynker.

Calati advocates for a more integrated approach across disciplines, institutions, and the community to provide an effective support network for those at risk. 

Accurately predicting suicide risk is challenging, she told this news organization. She and colleagues are working to develop more precise predictive tools for identifying individuals at risk, often by leveraging artificial intelligence and data analytics. They have designed and implemented app-based interventions for psychiatric patients at risk for suicide and university students with psychological distress. The interventions are personalized and based on multiple approaches, such as cognitive-behavioral therapy (CBT) and third-wave CBT. 

The results of current studies are preliminary, she acknowledged, “but even if apps are extremely complex, our projects received high interest from participants and the scientific community,” she said. The aim now is to integrate these tools into healthcare systems so that monitoring high-risk patients becomes part of regular care. 

Another area of focus is the identification of specific subtypes of individuals at risk for suicide, particularly by examining factors such as pain, dissociation, and interoception — the ability to sense and interpret internal signals from the body. 

“By understanding how these experiences intersect and contribute to suicide risk, I aim to identify distinct profiles within at-risk populations, which could ultimately enable more tailored and effective prevention efforts,” she said.

Her work also involves meta-research to build large, comprehensive datasets that increase statistical power for exploring suicide risk factors, such as physical health conditions and symptoms associated with borderline personality disorder. By creating these datasets, she aims to “improve understanding of how various factors contribute to suicide risk, ultimately supporting more effective prevention strategies.”

 

Country-Level Efforts

Preventive work is underway in other countries as well. In Nordic countries such as Denmark, Finland, and Sweden, large-scale national registries that track people’s medical histories, prescriptions, and demographic information are being used to develop predictive algorithms that identify those at high risk for suicide. The predictions are based on known risk factors like previous mental health diagnoses, substance abuse, and social determinants of health.

A recent Norwegian study found that a novel assessment tool used at admission to an acute inpatient unit was a powerful predictor of suicide within 3 years post-discharge.

Researchers in the Netherlands have also recently co-designed a digital integrated suicide prevention program, which has led to a significant reduction in suicide mortality. 

SUPREMOCOL (suicide prevention by monitoring and collaborative care) was implemented in Noord-Brabant, a province in the Netherlands that historically had high suicide rates. It combines technology and personal care, allowing healthcare providers to track a person’s mental health, including by phone calls, text messages, and mobile apps that help people express their feelings and report any changes in their mental state. By staying connected, the program aims to identify warning signs early and provide timely interventions.

The results from the 5-year project showed that rates dropped by 21.5%, from 14.4 per 100,000 to 11.8 per 100,000, and remained low, with a rate of 11.3 per 100,000 by 2021.

Finland used to have one of the highest suicide rates in the world. Now it is implementing its suicide prevention program for 2020-2030, with 36 proposed measures to prevent suicide mortality. 

The program includes measures such as increasing public awareness, early intervention, supporting at-risk groups, developing new treatment options, and enhancing research efforts. Earlier successful interventions included limiting access to firearms and poison, and increasing use of antidepressants and other targeted interventions.

“A key is to ensure that the individuals at risk of suicide have access to adequate, timely, and evidence-based care,” said Timo Partonen, MD, research professor at the Finnish Institute for Health and Welfare and associate professor of psychiatry at the University of Helsinki.

“Emergency and frontline professionals, as well as general practitioners and occupational health physicians, have a key role in identifying people at risk of suicide,” he noted. “High-quality competencies will be developed for healthcare professionals, including access to evidence-based suicide prevention models for addressing and assessing suicide risk.” 

 

Global Strategies

Policymakers across Europe are increasingly recognizing the importance of enhanced public health approaches to suicide prevention. 

The recently adopted EU Action Plan on Mental Health emphasizes the need for comprehensive suicide prevention strategies across Europe, including the promotion of mental health literacy and the provision of accessible mental health services.

The plan was informed by initiatives such as the European Alliance Against Depression (EAAD)-Best project, which ran from 2021 until March 2024. The collaborative project brought together researchers, healthcare providers, and community organizations to improve care for patients with depression and to prevent suicidal behavior in Europe. 

The multimodal approach included community engagement and training for healthcare professionals, as well as promoting the international uptake of the iFightDepression tool, an internet-based self-management approach for patients with depression. It has shown promise in reducing suicide rates in participating regions, including Europe, Australia, South America, and Africa.

“What we now know is that multiple interventions produce a synergic effect with a tendency to reduce suicidal behavior,” said EAAD founding member Ricardo Gusmão, MD, PhD, professor of public mental health at the University of Porto, Portugal. Current approaches to suicide prevention globally vary widely, with “many, fragmentary, atomized interventions, and we know that none of them, in isolation, produces spectacular results.” 

Gusmão explained that promising national suicide prevention strategies are based on multicomponent community interventions. On the clinical side, they encompass training primary health and specialized mental health professionals, and have a guaranteed chain of care and functioning pathways for access. They also involve educational programs in schools, universities, prisons, work settings, and geriatric care centers. Additionally, they have well-developed good standards for media communication and health marketing campaigns on well-being and mental health literacy.

Relevant and cohesive themes for successful strategies include the promotion of positive mental health, the identification and available treatments for depression and common mental disorders, and the management of suicidal crisis stigma. 

“We are now focusing on workplace settings and vulnerable groups such as youth, the elderly, unemployed, migrants and, of course, people affected by mental disorders,” he said. “Suicide prevention is like a web that must be weaved by long-lasting efforts and intersectoral collaboration.”

“Even one suicide is one too many,” Brendan Kelly, MD, PhD, professor of psychiatry, Trinity College Dublin, and author of The Modern Psychiatrist’s Guide to Contemporary Practice, told this news organization. “Nobody is born wanting to die by suicide. And every suicide is an individual tragedy, not a statistic. We need to work ever more intensively to reduce rates of suicide. All contributions to research and fresh thinking are welcome.”

Galynker, Calati, Partonen, and Kelly have disclosed no relevant financial relationships.  Gusmão has been involved in organizing Janssen-funded trainings for registrars on suicidal crisis management. 

 

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

Suicide and self-harm continue to be serious concerns in Europe, despite decreasing rates over the past two decades. In 2021 alone, 47,346 people died by suicide in the European Union, close to 1% of all deaths reported that year. Measures have been taken at population, subpopulation, and individual levels to prevent suicide and suicide attempts. But can more be done? Yes, according to experts.

Researchers are investigating factors that contribute to suicide at the individual level, as well as environmental and societal pressures that may increase risk. New predictive tools show promise in identifying individuals at high risk, and ongoing programs offer hope for early and ongoing interventions. Successful preventive strategies are multimodal, emphasizing the need for trained primary care and mental health professionals to work together to identify and support individuals at risk at every age and in all settings.

 

‘Radical Change’ Needed

The medical community’s approach to suicide prevention is all wrong, according to Igor Galynker, MD, PhD, clinical professor of psychiatry and director of the Mount Sinai Suicide Prevention Research Lab in New York City. 

Galynker is collaborating with colleagues in various parts of the world, including Europe, to validate the use of suicide crisis syndrome (SCS) as a diagnosis to help imminent suicide risk evaluation and treatment.

SCS is a negative cognitive-affective state associated with imminent suicidal behavior in those who are already at high risk for suicide. Galynker and his colleagues want to see SCS recognized and accepted as a suicide-specific diagnosis in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. 

Currently, he explained to this news organization, clinicians depend on a person at risk for suicide telling them that this is what they are feeling. This is “absurd,” he said, because people in this situation are in acute pain and distress and cannot answer accurately.

“It is the most lethal psychiatric condition, because people die from it ... yet we rely on people at the worst moment of their lives to tell us accurately when and how they are going to kill themselves. We don’t ask people with serious mental illness to diagnose their own mental illness and rely on that diagnosis.”

Data show that most people who attempt or die by suicide deny suicidal thoughts when assessed by healthcare providers using current questionnaires and scales. Thus, there needs to be “a radical change” in how patients at acute risk are assessed and treated to help “prevent suicides and avoid lost opportunities to intervene,” he said.

Galynker explained that SCS is the final and most acute stage of the “ narrative crisis model” of suicide, which reflects the progression of suicidal risk from chronic risk factors to imminent suicidal risk. “The narrative crisis model has four distinct and successive stages, with specific guidance and applicable interventions that enable patients to receive a stage-specific treatment.”

“Suicide crisis syndrome is a very treatable syndrome that rapidly resolves” with appropriate interventions, he said. “Once it is treated, the patient can engage with psychotherapy and other treatments.”

Galynker said he and his colleagues have had encouraging results with their studies so far on the subjective and objective views of clinicians using the risk assessment tools they are developing to assess suicidal ideation. Further studies are ongoing. 

 

Improving Prediction

There is definitely room for improvement in current approaches to suicide prevention, said Raffaella Calati, PhD, assistant professor of clinical psychology at the University of Milano-Bicocca, Italy, who has had research collaborations with Galynker.

Calati advocates for a more integrated approach across disciplines, institutions, and the community to provide an effective support network for those at risk. 

Accurately predicting suicide risk is challenging, she told this news organization. She and colleagues are working to develop more precise predictive tools for identifying individuals at risk, often by leveraging artificial intelligence and data analytics. They have designed and implemented app-based interventions for psychiatric patients at risk for suicide and university students with psychological distress. The interventions are personalized and based on multiple approaches, such as cognitive-behavioral therapy (CBT) and third-wave CBT. 

The results of current studies are preliminary, she acknowledged, “but even if apps are extremely complex, our projects received high interest from participants and the scientific community,” she said. The aim now is to integrate these tools into healthcare systems so that monitoring high-risk patients becomes part of regular care. 

Another area of focus is the identification of specific subtypes of individuals at risk for suicide, particularly by examining factors such as pain, dissociation, and interoception — the ability to sense and interpret internal signals from the body. 

“By understanding how these experiences intersect and contribute to suicide risk, I aim to identify distinct profiles within at-risk populations, which could ultimately enable more tailored and effective prevention efforts,” she said.

Her work also involves meta-research to build large, comprehensive datasets that increase statistical power for exploring suicide risk factors, such as physical health conditions and symptoms associated with borderline personality disorder. By creating these datasets, she aims to “improve understanding of how various factors contribute to suicide risk, ultimately supporting more effective prevention strategies.”

 

Country-Level Efforts

Preventive work is underway in other countries as well. In Nordic countries such as Denmark, Finland, and Sweden, large-scale national registries that track people’s medical histories, prescriptions, and demographic information are being used to develop predictive algorithms that identify those at high risk for suicide. The predictions are based on known risk factors like previous mental health diagnoses, substance abuse, and social determinants of health.

A recent Norwegian study found that a novel assessment tool used at admission to an acute inpatient unit was a powerful predictor of suicide within 3 years post-discharge.

Researchers in the Netherlands have also recently co-designed a digital integrated suicide prevention program, which has led to a significant reduction in suicide mortality. 

SUPREMOCOL (suicide prevention by monitoring and collaborative care) was implemented in Noord-Brabant, a province in the Netherlands that historically had high suicide rates. It combines technology and personal care, allowing healthcare providers to track a person’s mental health, including by phone calls, text messages, and mobile apps that help people express their feelings and report any changes in their mental state. By staying connected, the program aims to identify warning signs early and provide timely interventions.

The results from the 5-year project showed that rates dropped by 21.5%, from 14.4 per 100,000 to 11.8 per 100,000, and remained low, with a rate of 11.3 per 100,000 by 2021.

Finland used to have one of the highest suicide rates in the world. Now it is implementing its suicide prevention program for 2020-2030, with 36 proposed measures to prevent suicide mortality. 

The program includes measures such as increasing public awareness, early intervention, supporting at-risk groups, developing new treatment options, and enhancing research efforts. Earlier successful interventions included limiting access to firearms and poison, and increasing use of antidepressants and other targeted interventions.

“A key is to ensure that the individuals at risk of suicide have access to adequate, timely, and evidence-based care,” said Timo Partonen, MD, research professor at the Finnish Institute for Health and Welfare and associate professor of psychiatry at the University of Helsinki.

“Emergency and frontline professionals, as well as general practitioners and occupational health physicians, have a key role in identifying people at risk of suicide,” he noted. “High-quality competencies will be developed for healthcare professionals, including access to evidence-based suicide prevention models for addressing and assessing suicide risk.” 

 

Global Strategies

Policymakers across Europe are increasingly recognizing the importance of enhanced public health approaches to suicide prevention. 

The recently adopted EU Action Plan on Mental Health emphasizes the need for comprehensive suicide prevention strategies across Europe, including the promotion of mental health literacy and the provision of accessible mental health services.

The plan was informed by initiatives such as the European Alliance Against Depression (EAAD)-Best project, which ran from 2021 until March 2024. The collaborative project brought together researchers, healthcare providers, and community organizations to improve care for patients with depression and to prevent suicidal behavior in Europe. 

The multimodal approach included community engagement and training for healthcare professionals, as well as promoting the international uptake of the iFightDepression tool, an internet-based self-management approach for patients with depression. It has shown promise in reducing suicide rates in participating regions, including Europe, Australia, South America, and Africa.

“What we now know is that multiple interventions produce a synergic effect with a tendency to reduce suicidal behavior,” said EAAD founding member Ricardo Gusmão, MD, PhD, professor of public mental health at the University of Porto, Portugal. Current approaches to suicide prevention globally vary widely, with “many, fragmentary, atomized interventions, and we know that none of them, in isolation, produces spectacular results.” 

Gusmão explained that promising national suicide prevention strategies are based on multicomponent community interventions. On the clinical side, they encompass training primary health and specialized mental health professionals, and have a guaranteed chain of care and functioning pathways for access. They also involve educational programs in schools, universities, prisons, work settings, and geriatric care centers. Additionally, they have well-developed good standards for media communication and health marketing campaigns on well-being and mental health literacy.

Relevant and cohesive themes for successful strategies include the promotion of positive mental health, the identification and available treatments for depression and common mental disorders, and the management of suicidal crisis stigma. 

“We are now focusing on workplace settings and vulnerable groups such as youth, the elderly, unemployed, migrants and, of course, people affected by mental disorders,” he said. “Suicide prevention is like a web that must be weaved by long-lasting efforts and intersectoral collaboration.”

“Even one suicide is one too many,” Brendan Kelly, MD, PhD, professor of psychiatry, Trinity College Dublin, and author of The Modern Psychiatrist’s Guide to Contemporary Practice, told this news organization. “Nobody is born wanting to die by suicide. And every suicide is an individual tragedy, not a statistic. We need to work ever more intensively to reduce rates of suicide. All contributions to research and fresh thinking are welcome.”

Galynker, Calati, Partonen, and Kelly have disclosed no relevant financial relationships.  Gusmão has been involved in organizing Janssen-funded trainings for registrars on suicidal crisis management. 

 

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

Suicide and self-harm continue to be serious concerns in Europe, despite decreasing rates over the past two decades. In 2021 alone, 47,346 people died by suicide in the European Union, close to 1% of all deaths reported that year. Measures have been taken at population, subpopulation, and individual levels to prevent suicide and suicide attempts. But can more be done? Yes, according to experts.

Researchers are investigating factors that contribute to suicide at the individual level, as well as environmental and societal pressures that may increase risk. New predictive tools show promise in identifying individuals at high risk, and ongoing programs offer hope for early and ongoing interventions. Successful preventive strategies are multimodal, emphasizing the need for trained primary care and mental health professionals to work together to identify and support individuals at risk at every age and in all settings.

 

‘Radical Change’ Needed

The medical community’s approach to suicide prevention is all wrong, according to Igor Galynker, MD, PhD, clinical professor of psychiatry and director of the Mount Sinai Suicide Prevention Research Lab in New York City. 

Galynker is collaborating with colleagues in various parts of the world, including Europe, to validate the use of suicide crisis syndrome (SCS) as a diagnosis to help imminent suicide risk evaluation and treatment.

SCS is a negative cognitive-affective state associated with imminent suicidal behavior in those who are already at high risk for suicide. Galynker and his colleagues want to see SCS recognized and accepted as a suicide-specific diagnosis in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. 

Currently, he explained to this news organization, clinicians depend on a person at risk for suicide telling them that this is what they are feeling. This is “absurd,” he said, because people in this situation are in acute pain and distress and cannot answer accurately.

“It is the most lethal psychiatric condition, because people die from it ... yet we rely on people at the worst moment of their lives to tell us accurately when and how they are going to kill themselves. We don’t ask people with serious mental illness to diagnose their own mental illness and rely on that diagnosis.”

Data show that most people who attempt or die by suicide deny suicidal thoughts when assessed by healthcare providers using current questionnaires and scales. Thus, there needs to be “a radical change” in how patients at acute risk are assessed and treated to help “prevent suicides and avoid lost opportunities to intervene,” he said.

Galynker explained that SCS is the final and most acute stage of the “ narrative crisis model” of suicide, which reflects the progression of suicidal risk from chronic risk factors to imminent suicidal risk. “The narrative crisis model has four distinct and successive stages, with specific guidance and applicable interventions that enable patients to receive a stage-specific treatment.”

“Suicide crisis syndrome is a very treatable syndrome that rapidly resolves” with appropriate interventions, he said. “Once it is treated, the patient can engage with psychotherapy and other treatments.”

Galynker said he and his colleagues have had encouraging results with their studies so far on the subjective and objective views of clinicians using the risk assessment tools they are developing to assess suicidal ideation. Further studies are ongoing. 

 

Improving Prediction

There is definitely room for improvement in current approaches to suicide prevention, said Raffaella Calati, PhD, assistant professor of clinical psychology at the University of Milano-Bicocca, Italy, who has had research collaborations with Galynker.

Calati advocates for a more integrated approach across disciplines, institutions, and the community to provide an effective support network for those at risk. 

Accurately predicting suicide risk is challenging, she told this news organization. She and colleagues are working to develop more precise predictive tools for identifying individuals at risk, often by leveraging artificial intelligence and data analytics. They have designed and implemented app-based interventions for psychiatric patients at risk for suicide and university students with psychological distress. The interventions are personalized and based on multiple approaches, such as cognitive-behavioral therapy (CBT) and third-wave CBT. 

The results of current studies are preliminary, she acknowledged, “but even if apps are extremely complex, our projects received high interest from participants and the scientific community,” she said. The aim now is to integrate these tools into healthcare systems so that monitoring high-risk patients becomes part of regular care. 

Another area of focus is the identification of specific subtypes of individuals at risk for suicide, particularly by examining factors such as pain, dissociation, and interoception — the ability to sense and interpret internal signals from the body. 

“By understanding how these experiences intersect and contribute to suicide risk, I aim to identify distinct profiles within at-risk populations, which could ultimately enable more tailored and effective prevention efforts,” she said.

Her work also involves meta-research to build large, comprehensive datasets that increase statistical power for exploring suicide risk factors, such as physical health conditions and symptoms associated with borderline personality disorder. By creating these datasets, she aims to “improve understanding of how various factors contribute to suicide risk, ultimately supporting more effective prevention strategies.”

 

Country-Level Efforts

Preventive work is underway in other countries as well. In Nordic countries such as Denmark, Finland, and Sweden, large-scale national registries that track people’s medical histories, prescriptions, and demographic information are being used to develop predictive algorithms that identify those at high risk for suicide. The predictions are based on known risk factors like previous mental health diagnoses, substance abuse, and social determinants of health.

A recent Norwegian study found that a novel assessment tool used at admission to an acute inpatient unit was a powerful predictor of suicide within 3 years post-discharge.

Researchers in the Netherlands have also recently co-designed a digital integrated suicide prevention program, which has led to a significant reduction in suicide mortality. 

SUPREMOCOL (suicide prevention by monitoring and collaborative care) was implemented in Noord-Brabant, a province in the Netherlands that historically had high suicide rates. It combines technology and personal care, allowing healthcare providers to track a person’s mental health, including by phone calls, text messages, and mobile apps that help people express their feelings and report any changes in their mental state. By staying connected, the program aims to identify warning signs early and provide timely interventions.

The results from the 5-year project showed that rates dropped by 21.5%, from 14.4 per 100,000 to 11.8 per 100,000, and remained low, with a rate of 11.3 per 100,000 by 2021.

Finland used to have one of the highest suicide rates in the world. Now it is implementing its suicide prevention program for 2020-2030, with 36 proposed measures to prevent suicide mortality. 

The program includes measures such as increasing public awareness, early intervention, supporting at-risk groups, developing new treatment options, and enhancing research efforts. Earlier successful interventions included limiting access to firearms and poison, and increasing use of antidepressants and other targeted interventions.

“A key is to ensure that the individuals at risk of suicide have access to adequate, timely, and evidence-based care,” said Timo Partonen, MD, research professor at the Finnish Institute for Health and Welfare and associate professor of psychiatry at the University of Helsinki.

“Emergency and frontline professionals, as well as general practitioners and occupational health physicians, have a key role in identifying people at risk of suicide,” he noted. “High-quality competencies will be developed for healthcare professionals, including access to evidence-based suicide prevention models for addressing and assessing suicide risk.” 

 

Global Strategies

Policymakers across Europe are increasingly recognizing the importance of enhanced public health approaches to suicide prevention. 

The recently adopted EU Action Plan on Mental Health emphasizes the need for comprehensive suicide prevention strategies across Europe, including the promotion of mental health literacy and the provision of accessible mental health services.

The plan was informed by initiatives such as the European Alliance Against Depression (EAAD)-Best project, which ran from 2021 until March 2024. The collaborative project brought together researchers, healthcare providers, and community organizations to improve care for patients with depression and to prevent suicidal behavior in Europe. 

The multimodal approach included community engagement and training for healthcare professionals, as well as promoting the international uptake of the iFightDepression tool, an internet-based self-management approach for patients with depression. It has shown promise in reducing suicide rates in participating regions, including Europe, Australia, South America, and Africa.

“What we now know is that multiple interventions produce a synergic effect with a tendency to reduce suicidal behavior,” said EAAD founding member Ricardo Gusmão, MD, PhD, professor of public mental health at the University of Porto, Portugal. Current approaches to suicide prevention globally vary widely, with “many, fragmentary, atomized interventions, and we know that none of them, in isolation, produces spectacular results.” 

Gusmão explained that promising national suicide prevention strategies are based on multicomponent community interventions. On the clinical side, they encompass training primary health and specialized mental health professionals, and have a guaranteed chain of care and functioning pathways for access. They also involve educational programs in schools, universities, prisons, work settings, and geriatric care centers. Additionally, they have well-developed good standards for media communication and health marketing campaigns on well-being and mental health literacy.

Relevant and cohesive themes for successful strategies include the promotion of positive mental health, the identification and available treatments for depression and common mental disorders, and the management of suicidal crisis stigma. 

“We are now focusing on workplace settings and vulnerable groups such as youth, the elderly, unemployed, migrants and, of course, people affected by mental disorders,” he said. “Suicide prevention is like a web that must be weaved by long-lasting efforts and intersectoral collaboration.”

“Even one suicide is one too many,” Brendan Kelly, MD, PhD, professor of psychiatry, Trinity College Dublin, and author of The Modern Psychiatrist’s Guide to Contemporary Practice, told this news organization. “Nobody is born wanting to die by suicide. And every suicide is an individual tragedy, not a statistic. We need to work ever more intensively to reduce rates of suicide. All contributions to research and fresh thinking are welcome.”

Galynker, Calati, Partonen, and Kelly have disclosed no relevant financial relationships.  Gusmão has been involved in organizing Janssen-funded trainings for registrars on suicidal crisis management. 

 

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

WASHINGTON — A fully automated ultrasound scanning system combined with artificial intelligence–based disease activity scoring performed as well as expert rheumatologists in hand joint assessment of patients with rheumatoid arthritis (RA), new research found.

The system, made by a Danish company called ROPCA, comprises an ultrasound scanner called ARTHUR (RA Ultrasound Robot) that interacts directly with the patient and scans 11 joints per hand and a neural network–based software system, DIANA (Diagnosis Aid Network for RA), that evaluates the images and monitors RA activity.

 

The combined system classifies the degree of RA according to the joint European Alliance of Associations for Rheumatology (EULAR)–Outcome Measures in Rheumatology (OMERACT) standards for RA diagnosis. It received a CE Mark in Europe in 2022 and is currently in use in six rheumatology clinics in Denmark, Germany, Switzerland, and Austria, with more to come, ROPCA Co-founder and Chief Medical Officer Søren A. Just, MD, said in an interview.

“Automated systems could help rheumatologists in the early detection and monitoring of arthritis diseases. Systems can be placed or move in areas with insufficient rheumatological expertise,” Just said during a special late-breaker session presentation at the annual meeting of the American College of Rheumatology (ACR).

He said in an interview: “Currently, there are so many people referred and few and fewer rheumatologists. So we need to think differently. We need good automated assistants.” As a screening tool, the system can determine whether a person with hand pain has RA or just osteoarthritis “and also can give the patient an immediate answer, instead of waiting sometimes up to 6 months to get the information.”

Just, who is also a senior physician in the Department of Internal Medicine at Odense University Hospital in Denmark, said that his department is also using the system to assess flares in patients with established RA. “They can have a blood sample taken. They’re scanned by the robot, and you can see if there is any disease activity. But I think that screening of patients with joint pain is the beginning.”

Asked to comment, session moderator Gregory C. Gardner, MD, Emeritus Professor in the Division of Rheumatology at the University of Washington, Seattle, and a member of the ACR conference program committee, said in an interview “one of the reasons we chose to feature this abstract is because we’re interested in science at the convergence. We really thought this was a potential way to move the field forward for rheumatologists.”

Gardner said it’s an advantage that the patient could potentially have an ARTHUR scan with a DIANA report and get blood tests done prior to a visit with the rheumatologist. “It’s really time-consuming for a human to do these studies, so if you automate it, that’s a step forward in terms of having the data available for the rheumatologist to view and use sequentially to follow how patients are doing.”

When introducing Just’s presentation, Gardner called it “the coolest abstract of the meeting.”

 

Both DIANA and ARTHUR Performed At Least as Well as Human Rheumatologists

In the study, 30 patients with RA underwent two scans by ARTHUR, followed by a scan from a rheumatologist specialist in musculoskeletal ultrasound. The scans were sent to DIANA, who graded the images according to the Global OMERACT-EULAR Synovitis Score, as did the human rheumatologist.

A “ground truth” was established by another human expert who evaluated both ARTHUR’s and the other rheumatologist’s images, blinded to the scanning method. The image with the highest disease activity was deemed “ground truth,” and agreement with that was assessed for the two individual methods.

 

Just showed a video of a patient being scanned by ARTHUR. The machine verbally guided her through removing her jewelry, applying the gel, and placing her hand on the screen under the scanner. ARTHUR’s arm moved around on the patient’s hand, locating the best angles to take grayscale images and Doppler images and Doppler video. The scan takes 15-20 minutes, and the images are stored, Just said.

The study patients had a mean age of 65 years, and 23 of the 30 were men. Their average disease duration was 11 years, and mean Disease Activity Score in 28 joints using C-reactive protein was 3.86, indicating moderate disease. A majority (73%) of patients were taking disease-modifying antirheumatic drugs, and about one third were taking biologics. ARTHUR scanned a total of 660 joints, and 564 scans were successful.

For repeatability between the two ARTHUR scans, percent exact agreement was 63% for synovial hypertrophy, 75% for Doppler activity, and 60% combined. Percent close (within a point) agreements were 93%, 94%, and 92%, respectively. Binary agreements as to whether the joint was healthy vs diseased were 88%, 91%, and 85%, respectively.

At the joint level, ARTHUR and DIANA’s percent exact agreement with ground truth was 49% for synovial hypertrophy, 63% for Doppler activity, and 48% combined. Binary agreements with disease vs healthy were 80%, 88%, and 78%, respectively.

The human rheumatologists scored very similarly. Percent exact agreement with ground truth was 51% for synovial hypertrophy, 64% for Doppler activity, and 50% combined. Percent close agreements were 94%, 94%, and 92%, respectively. And binary agreements with diseased vs healthy were 83%, 91%, and 80%, respectively.

At the patient level (all joints combined), ARTHUR and DIANA’s binary disease assessment of healthy vs disease showed agreement with the ground truth of 87% for synovial hypertrophy, 83% for Doppler activity, and 87% combined. Here, the rheumatologists scored lower, at 53%, 67%, and 60%, respectively.

“In this study, we think the precision of ARTHUR and DIANA was comparable to that of an experienced rheumatologist, at both the joint and patient level,” Just said.

Gardner pointed out another advantage of the system. “DIANA doesn’t get fatigued. ... With human reading, the precision may change based on the time of day or stress level. ... But with DIANA, you’re going to get consistent information.”

Just said that the Arthritis Foundation in Germany recently put ARTHUR and DIANA on a bus and took it to cities that lacked a rheumatologist. Patients lined up, answered a questionnaire, had blood drawn, and received their scans. A rheumatologist on the bus then interpreted the data and consulted with the individuals about their RA risk. “In the last trip, we screened 800 patients in 6 days. So there are definitely possibilities here.”

Just is co-owner of ROPCA. Gardner had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — A fully automated ultrasound scanning system combined with artificial intelligence–based disease activity scoring performed as well as expert rheumatologists in hand joint assessment of patients with rheumatoid arthritis (RA), new research found.

The system, made by a Danish company called ROPCA, comprises an ultrasound scanner called ARTHUR (RA Ultrasound Robot) that interacts directly with the patient and scans 11 joints per hand and a neural network–based software system, DIANA (Diagnosis Aid Network for RA), that evaluates the images and monitors RA activity.

 

The combined system classifies the degree of RA according to the joint European Alliance of Associations for Rheumatology (EULAR)–Outcome Measures in Rheumatology (OMERACT) standards for RA diagnosis. It received a CE Mark in Europe in 2022 and is currently in use in six rheumatology clinics in Denmark, Germany, Switzerland, and Austria, with more to come, ROPCA Co-founder and Chief Medical Officer Søren A. Just, MD, said in an interview.

“Automated systems could help rheumatologists in the early detection and monitoring of arthritis diseases. Systems can be placed or move in areas with insufficient rheumatological expertise,” Just said during a special late-breaker session presentation at the annual meeting of the American College of Rheumatology (ACR).

He said in an interview: “Currently, there are so many people referred and few and fewer rheumatologists. So we need to think differently. We need good automated assistants.” As a screening tool, the system can determine whether a person with hand pain has RA or just osteoarthritis “and also can give the patient an immediate answer, instead of waiting sometimes up to 6 months to get the information.”

Just, who is also a senior physician in the Department of Internal Medicine at Odense University Hospital in Denmark, said that his department is also using the system to assess flares in patients with established RA. “They can have a blood sample taken. They’re scanned by the robot, and you can see if there is any disease activity. But I think that screening of patients with joint pain is the beginning.”

Asked to comment, session moderator Gregory C. Gardner, MD, Emeritus Professor in the Division of Rheumatology at the University of Washington, Seattle, and a member of the ACR conference program committee, said in an interview “one of the reasons we chose to feature this abstract is because we’re interested in science at the convergence. We really thought this was a potential way to move the field forward for rheumatologists.”

Gardner said it’s an advantage that the patient could potentially have an ARTHUR scan with a DIANA report and get blood tests done prior to a visit with the rheumatologist. “It’s really time-consuming for a human to do these studies, so if you automate it, that’s a step forward in terms of having the data available for the rheumatologist to view and use sequentially to follow how patients are doing.”

When introducing Just’s presentation, Gardner called it “the coolest abstract of the meeting.”

 

Both DIANA and ARTHUR Performed At Least as Well as Human Rheumatologists

In the study, 30 patients with RA underwent two scans by ARTHUR, followed by a scan from a rheumatologist specialist in musculoskeletal ultrasound. The scans were sent to DIANA, who graded the images according to the Global OMERACT-EULAR Synovitis Score, as did the human rheumatologist.

A “ground truth” was established by another human expert who evaluated both ARTHUR’s and the other rheumatologist’s images, blinded to the scanning method. The image with the highest disease activity was deemed “ground truth,” and agreement with that was assessed for the two individual methods.

 

Just showed a video of a patient being scanned by ARTHUR. The machine verbally guided her through removing her jewelry, applying the gel, and placing her hand on the screen under the scanner. ARTHUR’s arm moved around on the patient’s hand, locating the best angles to take grayscale images and Doppler images and Doppler video. The scan takes 15-20 minutes, and the images are stored, Just said.

The study patients had a mean age of 65 years, and 23 of the 30 were men. Their average disease duration was 11 years, and mean Disease Activity Score in 28 joints using C-reactive protein was 3.86, indicating moderate disease. A majority (73%) of patients were taking disease-modifying antirheumatic drugs, and about one third were taking biologics. ARTHUR scanned a total of 660 joints, and 564 scans were successful.

For repeatability between the two ARTHUR scans, percent exact agreement was 63% for synovial hypertrophy, 75% for Doppler activity, and 60% combined. Percent close (within a point) agreements were 93%, 94%, and 92%, respectively. Binary agreements as to whether the joint was healthy vs diseased were 88%, 91%, and 85%, respectively.

At the joint level, ARTHUR and DIANA’s percent exact agreement with ground truth was 49% for synovial hypertrophy, 63% for Doppler activity, and 48% combined. Binary agreements with disease vs healthy were 80%, 88%, and 78%, respectively.

The human rheumatologists scored very similarly. Percent exact agreement with ground truth was 51% for synovial hypertrophy, 64% for Doppler activity, and 50% combined. Percent close agreements were 94%, 94%, and 92%, respectively. And binary agreements with diseased vs healthy were 83%, 91%, and 80%, respectively.

At the patient level (all joints combined), ARTHUR and DIANA’s binary disease assessment of healthy vs disease showed agreement with the ground truth of 87% for synovial hypertrophy, 83% for Doppler activity, and 87% combined. Here, the rheumatologists scored lower, at 53%, 67%, and 60%, respectively.

“In this study, we think the precision of ARTHUR and DIANA was comparable to that of an experienced rheumatologist, at both the joint and patient level,” Just said.

Gardner pointed out another advantage of the system. “DIANA doesn’t get fatigued. ... With human reading, the precision may change based on the time of day or stress level. ... But with DIANA, you’re going to get consistent information.”

Just said that the Arthritis Foundation in Germany recently put ARTHUR and DIANA on a bus and took it to cities that lacked a rheumatologist. Patients lined up, answered a questionnaire, had blood drawn, and received their scans. A rheumatologist on the bus then interpreted the data and consulted with the individuals about their RA risk. “In the last trip, we screened 800 patients in 6 days. So there are definitely possibilities here.”

Just is co-owner of ROPCA. Gardner had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — A fully automated ultrasound scanning system combined with artificial intelligence–based disease activity scoring performed as well as expert rheumatologists in hand joint assessment of patients with rheumatoid arthritis (RA), new research found.

The system, made by a Danish company called ROPCA, comprises an ultrasound scanner called ARTHUR (RA Ultrasound Robot) that interacts directly with the patient and scans 11 joints per hand and a neural network–based software system, DIANA (Diagnosis Aid Network for RA), that evaluates the images and monitors RA activity.

 

The combined system classifies the degree of RA according to the joint European Alliance of Associations for Rheumatology (EULAR)–Outcome Measures in Rheumatology (OMERACT) standards for RA diagnosis. It received a CE Mark in Europe in 2022 and is currently in use in six rheumatology clinics in Denmark, Germany, Switzerland, and Austria, with more to come, ROPCA Co-founder and Chief Medical Officer Søren A. Just, MD, said in an interview.

“Automated systems could help rheumatologists in the early detection and monitoring of arthritis diseases. Systems can be placed or move in areas with insufficient rheumatological expertise,” Just said during a special late-breaker session presentation at the annual meeting of the American College of Rheumatology (ACR).

He said in an interview: “Currently, there are so many people referred and few and fewer rheumatologists. So we need to think differently. We need good automated assistants.” As a screening tool, the system can determine whether a person with hand pain has RA or just osteoarthritis “and also can give the patient an immediate answer, instead of waiting sometimes up to 6 months to get the information.”

Just, who is also a senior physician in the Department of Internal Medicine at Odense University Hospital in Denmark, said that his department is also using the system to assess flares in patients with established RA. “They can have a blood sample taken. They’re scanned by the robot, and you can see if there is any disease activity. But I think that screening of patients with joint pain is the beginning.”

Asked to comment, session moderator Gregory C. Gardner, MD, Emeritus Professor in the Division of Rheumatology at the University of Washington, Seattle, and a member of the ACR conference program committee, said in an interview “one of the reasons we chose to feature this abstract is because we’re interested in science at the convergence. We really thought this was a potential way to move the field forward for rheumatologists.”

Gardner said it’s an advantage that the patient could potentially have an ARTHUR scan with a DIANA report and get blood tests done prior to a visit with the rheumatologist. “It’s really time-consuming for a human to do these studies, so if you automate it, that’s a step forward in terms of having the data available for the rheumatologist to view and use sequentially to follow how patients are doing.”

When introducing Just’s presentation, Gardner called it “the coolest abstract of the meeting.”

 

Both DIANA and ARTHUR Performed At Least as Well as Human Rheumatologists

In the study, 30 patients with RA underwent two scans by ARTHUR, followed by a scan from a rheumatologist specialist in musculoskeletal ultrasound. The scans were sent to DIANA, who graded the images according to the Global OMERACT-EULAR Synovitis Score, as did the human rheumatologist.

A “ground truth” was established by another human expert who evaluated both ARTHUR’s and the other rheumatologist’s images, blinded to the scanning method. The image with the highest disease activity was deemed “ground truth,” and agreement with that was assessed for the two individual methods.

 

Just showed a video of a patient being scanned by ARTHUR. The machine verbally guided her through removing her jewelry, applying the gel, and placing her hand on the screen under the scanner. ARTHUR’s arm moved around on the patient’s hand, locating the best angles to take grayscale images and Doppler images and Doppler video. The scan takes 15-20 minutes, and the images are stored, Just said.

The study patients had a mean age of 65 years, and 23 of the 30 were men. Their average disease duration was 11 years, and mean Disease Activity Score in 28 joints using C-reactive protein was 3.86, indicating moderate disease. A majority (73%) of patients were taking disease-modifying antirheumatic drugs, and about one third were taking biologics. ARTHUR scanned a total of 660 joints, and 564 scans were successful.

For repeatability between the two ARTHUR scans, percent exact agreement was 63% for synovial hypertrophy, 75% for Doppler activity, and 60% combined. Percent close (within a point) agreements were 93%, 94%, and 92%, respectively. Binary agreements as to whether the joint was healthy vs diseased were 88%, 91%, and 85%, respectively.

At the joint level, ARTHUR and DIANA’s percent exact agreement with ground truth was 49% for synovial hypertrophy, 63% for Doppler activity, and 48% combined. Binary agreements with disease vs healthy were 80%, 88%, and 78%, respectively.

The human rheumatologists scored very similarly. Percent exact agreement with ground truth was 51% for synovial hypertrophy, 64% for Doppler activity, and 50% combined. Percent close agreements were 94%, 94%, and 92%, respectively. And binary agreements with diseased vs healthy were 83%, 91%, and 80%, respectively.

At the patient level (all joints combined), ARTHUR and DIANA’s binary disease assessment of healthy vs disease showed agreement with the ground truth of 87% for synovial hypertrophy, 83% for Doppler activity, and 87% combined. Here, the rheumatologists scored lower, at 53%, 67%, and 60%, respectively.

“In this study, we think the precision of ARTHUR and DIANA was comparable to that of an experienced rheumatologist, at both the joint and patient level,” Just said.

Gardner pointed out another advantage of the system. “DIANA doesn’t get fatigued. ... With human reading, the precision may change based on the time of day or stress level. ... But with DIANA, you’re going to get consistent information.”

Just said that the Arthritis Foundation in Germany recently put ARTHUR and DIANA on a bus and took it to cities that lacked a rheumatologist. Patients lined up, answered a questionnaire, had blood drawn, and received their scans. A rheumatologist on the bus then interpreted the data and consulted with the individuals about their RA risk. “In the last trip, we screened 800 patients in 6 days. So there are definitely possibilities here.”

Just is co-owner of ROPCA. Gardner had no disclosures.

A version of this article appeared on Medscape.com.

A Mediterranean-inspired plant-based diet improved self-reported measures of gout as well as uric acid levels, a pilot study has found. 

There hasn’t been a lot of research on diet in gout, according to Anna Kretova, RD, who presented the study at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network. She noted that a 2019 systematic review of low-calorie diets, low-purine diets, and Mediterranean diets found that uric acid levels below 0.6 mmol/L were achieved only in those on the Mediterranean diet (Nutrients. 2019 Dec 4;11[12]:2955). A 2020 study compared a low-fat, high-carbohydrate, plant-based diet vs an animal-based, ketogenic diet in healthy individuals. After 2 weeks, uric acid levels increased in those on the animal-based, low-carb diet and decreased in those on the plant-based diet. 

Some foods are considered to be proinflammatory and generally come from animal origins, including saturated fats and animal protein in addition to ultraprocessed foods. Foods that have anti-inflammatory properties are mostly plant based and unprocessed and often rich in fiber. “From recent interventional studies, we also know that the whole-foods plant-based diet has shown to be effective as treatments of the main comorbidities of gout, such as obesity, cardiovascular disease, or [osteoarthritis],” said Kretova, who is a registered dietitian and a researcher at the Reade Rehabilitation and Rheumatology Center, Amsterdam, the Netherlands. 

Those findings led the researchers to develop a whole-foods, plant-based diet and test its effect on serum uric acid in patients with gout, as well as gout disease activity and cardiovascular disease risk. Participants could not eat meat, fish, eggs, or dairy. 

The trial included 33 individuals with gout who were randomized to a 16-week intervention with five consultations with a registered dietitian (n = 18) or a wait-list control group (n = 15) who received standard care. The mean age overall was 52 years, and 91% were men. The mean body mass index (BMI) was 32.6 kg/m2, and the median uric acid level was 0.50 mmol/L (8.4 mg/dL).

Among gout-related outcomes, the researchers noted improvements in gout severity as measured by visual analog scale (VAS; between group difference, –2.0; P =.01), pain as measured by VAS (between group difference, –2.0; P =.04), and uric acid levels after adjustment for age, sex, and BMI (between group difference, –0.05 mmol/L, P =.004). There were also improvements in the intervention group in weight loss (between group difference, –5.3 kg; P <.0001), BMI (between group difference, –1.7; P < .0001), waist circumference (between group difference, –3.9 cm; P = .004), and low-density lipoprotein (LDL) cholesterol (between group difference, –0.5; P = .007).

At 16 weeks, “we concluded that a Mediterranean-inspired whole-foods, plant-based diet significantly lowers serum uric acid in patients with gout and abdominal obesity, and additionally, the diet reduces gout-related pain and disease activity, promotes substantial weight loss, decreases weight circumference, and improves LDL cholesterol levels, and thus decreases [cardiovascular disease] risk in these patients,” Kretova said. 

She added that some might question whether a uric acid reduction of –0.05 mmol/L is clinically relevant. “We would argue it is because of the strong decrease in disease activity and pain in the intervention group,” Kretova said. 

The study is limited by its small size, the fact that it was not blinded, and the 4-month duration, which might be too short to capture potential indirect effects of diet on hyperuricemia and chronic inflammation, Kretova said. The group is planning to follow participants out to 12 months in an extension study.

During the Q&A session after the presentation, an audience member asked if the participants were vegetarians before they entered the study, and whether the dietary change could be sustained. “It’s a very good proof-of-concept study, but whether an intervention based entirely on plant-based therapy will be something that patients will be able to adhere to long term [is uncertain],” Kretova said.

She was optimistic, even though the participants generally enjoyed food and ate a lot of red meat. “I think there will be a gradation of people who can sustain and who cannot sustain [the diet]. From what we saw, people actually found it easier to follow than they expected, and a lot of participants changed their diet permanently for the better. Not everyone became [entirely] plant-based, but they became much more plant-based than they expected from themselves. So, it is definitely feasible,” she said.

Kretova reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A Mediterranean-inspired plant-based diet improved self-reported measures of gout as well as uric acid levels, a pilot study has found. 

There hasn’t been a lot of research on diet in gout, according to Anna Kretova, RD, who presented the study at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network. She noted that a 2019 systematic review of low-calorie diets, low-purine diets, and Mediterranean diets found that uric acid levels below 0.6 mmol/L were achieved only in those on the Mediterranean diet (Nutrients. 2019 Dec 4;11[12]:2955). A 2020 study compared a low-fat, high-carbohydrate, plant-based diet vs an animal-based, ketogenic diet in healthy individuals. After 2 weeks, uric acid levels increased in those on the animal-based, low-carb diet and decreased in those on the plant-based diet. 

Some foods are considered to be proinflammatory and generally come from animal origins, including saturated fats and animal protein in addition to ultraprocessed foods. Foods that have anti-inflammatory properties are mostly plant based and unprocessed and often rich in fiber. “From recent interventional studies, we also know that the whole-foods plant-based diet has shown to be effective as treatments of the main comorbidities of gout, such as obesity, cardiovascular disease, or [osteoarthritis],” said Kretova, who is a registered dietitian and a researcher at the Reade Rehabilitation and Rheumatology Center, Amsterdam, the Netherlands. 

Those findings led the researchers to develop a whole-foods, plant-based diet and test its effect on serum uric acid in patients with gout, as well as gout disease activity and cardiovascular disease risk. Participants could not eat meat, fish, eggs, or dairy. 

The trial included 33 individuals with gout who were randomized to a 16-week intervention with five consultations with a registered dietitian (n = 18) or a wait-list control group (n = 15) who received standard care. The mean age overall was 52 years, and 91% were men. The mean body mass index (BMI) was 32.6 kg/m2, and the median uric acid level was 0.50 mmol/L (8.4 mg/dL).

Among gout-related outcomes, the researchers noted improvements in gout severity as measured by visual analog scale (VAS; between group difference, –2.0; P =.01), pain as measured by VAS (between group difference, –2.0; P =.04), and uric acid levels after adjustment for age, sex, and BMI (between group difference, –0.05 mmol/L, P =.004). There were also improvements in the intervention group in weight loss (between group difference, –5.3 kg; P <.0001), BMI (between group difference, –1.7; P < .0001), waist circumference (between group difference, –3.9 cm; P = .004), and low-density lipoprotein (LDL) cholesterol (between group difference, –0.5; P = .007).

At 16 weeks, “we concluded that a Mediterranean-inspired whole-foods, plant-based diet significantly lowers serum uric acid in patients with gout and abdominal obesity, and additionally, the diet reduces gout-related pain and disease activity, promotes substantial weight loss, decreases weight circumference, and improves LDL cholesterol levels, and thus decreases [cardiovascular disease] risk in these patients,” Kretova said. 

She added that some might question whether a uric acid reduction of –0.05 mmol/L is clinically relevant. “We would argue it is because of the strong decrease in disease activity and pain in the intervention group,” Kretova said. 

The study is limited by its small size, the fact that it was not blinded, and the 4-month duration, which might be too short to capture potential indirect effects of diet on hyperuricemia and chronic inflammation, Kretova said. The group is planning to follow participants out to 12 months in an extension study.

During the Q&A session after the presentation, an audience member asked if the participants were vegetarians before they entered the study, and whether the dietary change could be sustained. “It’s a very good proof-of-concept study, but whether an intervention based entirely on plant-based therapy will be something that patients will be able to adhere to long term [is uncertain],” Kretova said.

She was optimistic, even though the participants generally enjoyed food and ate a lot of red meat. “I think there will be a gradation of people who can sustain and who cannot sustain [the diet]. From what we saw, people actually found it easier to follow than they expected, and a lot of participants changed their diet permanently for the better. Not everyone became [entirely] plant-based, but they became much more plant-based than they expected from themselves. So, it is definitely feasible,” she said.

Kretova reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A Mediterranean-inspired plant-based diet improved self-reported measures of gout as well as uric acid levels, a pilot study has found. 

There hasn’t been a lot of research on diet in gout, according to Anna Kretova, RD, who presented the study at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network. She noted that a 2019 systematic review of low-calorie diets, low-purine diets, and Mediterranean diets found that uric acid levels below 0.6 mmol/L were achieved only in those on the Mediterranean diet (Nutrients. 2019 Dec 4;11[12]:2955). A 2020 study compared a low-fat, high-carbohydrate, plant-based diet vs an animal-based, ketogenic diet in healthy individuals. After 2 weeks, uric acid levels increased in those on the animal-based, low-carb diet and decreased in those on the plant-based diet. 

Some foods are considered to be proinflammatory and generally come from animal origins, including saturated fats and animal protein in addition to ultraprocessed foods. Foods that have anti-inflammatory properties are mostly plant based and unprocessed and often rich in fiber. “From recent interventional studies, we also know that the whole-foods plant-based diet has shown to be effective as treatments of the main comorbidities of gout, such as obesity, cardiovascular disease, or [osteoarthritis],” said Kretova, who is a registered dietitian and a researcher at the Reade Rehabilitation and Rheumatology Center, Amsterdam, the Netherlands. 

Those findings led the researchers to develop a whole-foods, plant-based diet and test its effect on serum uric acid in patients with gout, as well as gout disease activity and cardiovascular disease risk. Participants could not eat meat, fish, eggs, or dairy. 

The trial included 33 individuals with gout who were randomized to a 16-week intervention with five consultations with a registered dietitian (n = 18) or a wait-list control group (n = 15) who received standard care. The mean age overall was 52 years, and 91% were men. The mean body mass index (BMI) was 32.6 kg/m2, and the median uric acid level was 0.50 mmol/L (8.4 mg/dL).

Among gout-related outcomes, the researchers noted improvements in gout severity as measured by visual analog scale (VAS; between group difference, –2.0; P =.01), pain as measured by VAS (between group difference, –2.0; P =.04), and uric acid levels after adjustment for age, sex, and BMI (between group difference, –0.05 mmol/L, P =.004). There were also improvements in the intervention group in weight loss (between group difference, –5.3 kg; P <.0001), BMI (between group difference, –1.7; P < .0001), waist circumference (between group difference, –3.9 cm; P = .004), and low-density lipoprotein (LDL) cholesterol (between group difference, –0.5; P = .007).

At 16 weeks, “we concluded that a Mediterranean-inspired whole-foods, plant-based diet significantly lowers serum uric acid in patients with gout and abdominal obesity, and additionally, the diet reduces gout-related pain and disease activity, promotes substantial weight loss, decreases weight circumference, and improves LDL cholesterol levels, and thus decreases [cardiovascular disease] risk in these patients,” Kretova said. 

She added that some might question whether a uric acid reduction of –0.05 mmol/L is clinically relevant. “We would argue it is because of the strong decrease in disease activity and pain in the intervention group,” Kretova said. 

The study is limited by its small size, the fact that it was not blinded, and the 4-month duration, which might be too short to capture potential indirect effects of diet on hyperuricemia and chronic inflammation, Kretova said. The group is planning to follow participants out to 12 months in an extension study.

During the Q&A session after the presentation, an audience member asked if the participants were vegetarians before they entered the study, and whether the dietary change could be sustained. “It’s a very good proof-of-concept study, but whether an intervention based entirely on plant-based therapy will be something that patients will be able to adhere to long term [is uncertain],” Kretova said.

She was optimistic, even though the participants generally enjoyed food and ate a lot of red meat. “I think there will be a gradation of people who can sustain and who cannot sustain [the diet]. From what we saw, people actually found it easier to follow than they expected, and a lot of participants changed their diet permanently for the better. Not everyone became [entirely] plant-based, but they became much more plant-based than they expected from themselves. So, it is definitely feasible,” she said.

Kretova reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE: 

Hypertension, atrial fibrillation, and smoking are more strongly linked to increased risk for severe stroke than nonsevere stroke, whereas a high waist-to-hip ratio is more closely associated with nonsevere stroke, a global study shows.

METHODOLOGY:

• The INTERSTROKE case-control study included nearly 27,000 participants, half of whom had a first acute stroke (ischemic or hemorrhagic) and the other half acting as age- and sex-matched controls.
• Participants (mean age, 62 years; 40% women) were recruited across 142 centers in 32 countries between 2007 and 2015. Baseline demographics and lifestyle risk factors for stroke were gathered using standardized questionnaires
• Modified Rankin Scale (mRS) scores measured within 72 hours of hospital admission were used to classify stroke severity (0-3, nonsevere stroke; 4-6, severe stroke).

TAKEAWAY:

• Among the participants with acute stroke, 64% had nonsevere stroke and 36% had severe stroke, based on the mRS.
• Hypertension, atrial fibrillation, and smoking showed a significantly stronger association with severe stroke than with nonsevere stroke (odds ratios [ORs], 3.21 vs 2.87, 4.70 vs 3.61, and 1.87 vs 1.65, respectively; all P < .001).
• A high waist-to-hip ratio showed a stronger association with nonsevere stroke than with severe stroke (OR, 1.37 vs 1.11, respectively; P < .001).
• Diabetes, poor diet, physical inactivity, and stress were linked to increased odds of both severe and nonsevere stroke, whereas alcohol consumption and high apolipoprotein B levels were linked to higher odds of only nonsevere stroke. No significant differences in odds were observed between stroke severities in matched individuals.

IN PRACTICE:

“Our findings emphasize the importance of controlling high blood pressure, which is the most important modifiable risk factor for stroke globally,” lead author Catriona Reddin, MB BCh, BAO, MSc, School of Medicine, University of Galway, in Ireland, said in a press release.

SOURCE:

The study was published online in Neurology.

LIMITATIONS:

The study limitations included potential unmeasured confounders; reliance on the mRS score, which may have underestimated stroke severity; and challenges with recruiting patients with severe stroke in a case-control study. Smoking-related comorbidities and regional or sex-related variations in alcohol intake may also have influenced the results.

DISCLOSURES:

The study was funded by various organizations, including health research councils and foundations from Canada, Sweden, and Scotland, and pharmaceutical companies such as AstraZeneca, Boehringer Ingelheim, Pfizer, and MSD. One investigator reported receiving funding from the Irish Clinical Academic Training Programme, the Wellcome Trust and the Health Research Board, the Health Service Executive, National Doctors Training and Planning, and the Health and Social Care, Research and Development Division in Northern Ireland. No other conflicts of interest were reported.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Hypertension, atrial fibrillation, and smoking are more strongly linked to increased risk for severe stroke than nonsevere stroke, whereas a high waist-to-hip ratio is more closely associated with nonsevere stroke, a global study shows.

METHODOLOGY:

• The INTERSTROKE case-control study included nearly 27,000 participants, half of whom had a first acute stroke (ischemic or hemorrhagic) and the other half acting as age- and sex-matched controls.
• Participants (mean age, 62 years; 40% women) were recruited across 142 centers in 32 countries between 2007 and 2015. Baseline demographics and lifestyle risk factors for stroke were gathered using standardized questionnaires
• Modified Rankin Scale (mRS) scores measured within 72 hours of hospital admission were used to classify stroke severity (0-3, nonsevere stroke; 4-6, severe stroke).

TAKEAWAY:

• Among the participants with acute stroke, 64% had nonsevere stroke and 36% had severe stroke, based on the mRS.
• Hypertension, atrial fibrillation, and smoking showed a significantly stronger association with severe stroke than with nonsevere stroke (odds ratios [ORs], 3.21 vs 2.87, 4.70 vs 3.61, and 1.87 vs 1.65, respectively; all P < .001).
• A high waist-to-hip ratio showed a stronger association with nonsevere stroke than with severe stroke (OR, 1.37 vs 1.11, respectively; P < .001).
• Diabetes, poor diet, physical inactivity, and stress were linked to increased odds of both severe and nonsevere stroke, whereas alcohol consumption and high apolipoprotein B levels were linked to higher odds of only nonsevere stroke. No significant differences in odds were observed between stroke severities in matched individuals.

IN PRACTICE:

“Our findings emphasize the importance of controlling high blood pressure, which is the most important modifiable risk factor for stroke globally,” lead author Catriona Reddin, MB BCh, BAO, MSc, School of Medicine, University of Galway, in Ireland, said in a press release.

SOURCE:

The study was published online in Neurology.

LIMITATIONS:

The study limitations included potential unmeasured confounders; reliance on the mRS score, which may have underestimated stroke severity; and challenges with recruiting patients with severe stroke in a case-control study. Smoking-related comorbidities and regional or sex-related variations in alcohol intake may also have influenced the results.

DISCLOSURES:

The study was funded by various organizations, including health research councils and foundations from Canada, Sweden, and Scotland, and pharmaceutical companies such as AstraZeneca, Boehringer Ingelheim, Pfizer, and MSD. One investigator reported receiving funding from the Irish Clinical Academic Training Programme, the Wellcome Trust and the Health Research Board, the Health Service Executive, National Doctors Training and Planning, and the Health and Social Care, Research and Development Division in Northern Ireland. No other conflicts of interest were reported.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Hypertension, atrial fibrillation, and smoking are more strongly linked to increased risk for severe stroke than nonsevere stroke, whereas a high waist-to-hip ratio is more closely associated with nonsevere stroke, a global study shows.

METHODOLOGY:

• The INTERSTROKE case-control study included nearly 27,000 participants, half of whom had a first acute stroke (ischemic or hemorrhagic) and the other half acting as age- and sex-matched controls.
• Participants (mean age, 62 years; 40% women) were recruited across 142 centers in 32 countries between 2007 and 2015. Baseline demographics and lifestyle risk factors for stroke were gathered using standardized questionnaires
• Modified Rankin Scale (mRS) scores measured within 72 hours of hospital admission were used to classify stroke severity (0-3, nonsevere stroke; 4-6, severe stroke).

TAKEAWAY:

• Among the participants with acute stroke, 64% had nonsevere stroke and 36% had severe stroke, based on the mRS.
• Hypertension, atrial fibrillation, and smoking showed a significantly stronger association with severe stroke than with nonsevere stroke (odds ratios [ORs], 3.21 vs 2.87, 4.70 vs 3.61, and 1.87 vs 1.65, respectively; all P < .001).
• A high waist-to-hip ratio showed a stronger association with nonsevere stroke than with severe stroke (OR, 1.37 vs 1.11, respectively; P < .001).
• Diabetes, poor diet, physical inactivity, and stress were linked to increased odds of both severe and nonsevere stroke, whereas alcohol consumption and high apolipoprotein B levels were linked to higher odds of only nonsevere stroke. No significant differences in odds were observed between stroke severities in matched individuals.

IN PRACTICE:

“Our findings emphasize the importance of controlling high blood pressure, which is the most important modifiable risk factor for stroke globally,” lead author Catriona Reddin, MB BCh, BAO, MSc, School of Medicine, University of Galway, in Ireland, said in a press release.

SOURCE:

The study was published online in Neurology.

LIMITATIONS:

The study limitations included potential unmeasured confounders; reliance on the mRS score, which may have underestimated stroke severity; and challenges with recruiting patients with severe stroke in a case-control study. Smoking-related comorbidities and regional or sex-related variations in alcohol intake may also have influenced the results.

DISCLOSURES:

The study was funded by various organizations, including health research councils and foundations from Canada, Sweden, and Scotland, and pharmaceutical companies such as AstraZeneca, Boehringer Ingelheim, Pfizer, and MSD. One investigator reported receiving funding from the Irish Clinical Academic Training Programme, the Wellcome Trust and the Health Research Board, the Health Service Executive, National Doctors Training and Planning, and the Health and Social Care, Research and Development Division in Northern Ireland. No other conflicts of interest were reported.

 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

WASHINGTON — The investigational anti-CD40 ligand agent dapirolizumab pegol (DZP) outperformed placebo in improving disease activity and reducing high-dose corticosteroid use in patients with systemic lupus erythematosus (SLE) in the phase 3 PHOENYCS GO trial.

“We really think that dapirolizumab pegol may represent a novel treatment for lupus, particularly given its broad immune modulatory effects,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She presented the study in a late-breaking poster session at the American College of Rheumatology (ACR) 2024 Annual Meeting.

There is a “huge unmet need” for drugs for lupus, Clowse told this news organization. Patients with SLE continue to have high disease burden, including ongoing symptoms often driven by inflammation. Corticosteroids are often the best medications to control disease activity, she said, but they can result in long-term toxicity.

 

What Makes DZP Unique?

Through CD40 ligand signaling, DZP has been shown to reduce B- and T-cell activation and to downregulate interferon pathways. Previous antibodies targeting the CD40 ligand have been associated with an increased risk for thromboembolic events. However, DZP lacks the Fc portion of the antibody, which can bind to platelets and cause clotting. Data from phase 1, 2, and 3 trials thus far do not show an elevated risk for these events, Clowse explained. In fact, safety signals were strong enough that patients with antiphospholipid antibodies — a key driver for blood clots in patients with SLE — were included in the trial.

In PHOENYCS GO, investigators enrolled 321 patients with moderate to severe SLE with persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medications such as antimalarials, corticosteroids, and immunosuppressants.

Patients were randomized 2:1 to receive intravenous DZP (24 mg/kg) plus SOC or intravenous placebo plus SOC every 4 weeks, with patients and investigators blinded to treatment assignments.

Patients taking a corticosteroid dose > 7.5 mg/day began a mandatory steroid taper by week 8 of the trial, with the goal of reducing that to < 7.5 mg/day. The tapering regimen was at the discretion of providers and was adapted to each patient’s individual disease activity.

The primary endpoint was British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response at week 48.

Patients in the DZP and placebo groups were on average 43.5 and 41.5 years old, respectively. More than 90% of patients were women, all on concomitant SLE medications. About half of the participants took a daily corticosteroid dose > 7.5 mg.

At 48 weeks, half of the DZP group (49.5%) achieved BICLA response compared with 34.6% in the placebo group (P = .0110). A higher proportion of patients taking DZP achieved SLE Responder Index-4 response than those taking placebo (60.1% vs 41.1%, respectively; P = .0014), and the rate of severe British Isles Lupus Assessment Group flares in the DZP group was half that of the placebo group (11.6% vs 23.4%; P = .0257). In the subgroup of patients who underwent corticosteroid tapering, 72.4% receiving DZP and 52.9% taking placebo reduced their dose to < 7.5 mg/day by 48 weeks (P = .0404).

DZP was generally well tolerated. Over 48 weeks, 82.6% of the DZP group and 75% of the placebo group reported treatment-emergent adverse events, but serious occurrences were more common in the placebo group (14.8%) than in the DZP group (9.9%). Herpes viral infections were higher in the placebo group, although there were three ophthalmic herpes cases in the DZP group. There was one case of acute myocardial infarction and one death linked to gangrene-related sepsis in patients receiving DZP.

 

A ‘Mild to Moderate’ Response

Although these are definitely positive results, they show a “mild to moderate response” to DZP, commented Gregory Gardner, MD, an emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, and chair of the American College of Rheumatology’s annual meeting planning committee. He moderated the session where the research was presented. Although DZP showed efficacy among some patients, he noted, “there were still 51% patients that it didn’t work for.” 

The drug uses an alternative pathway to current lupus drugs, Gardner added, and more research is needed to understand how best to use this medication in practice.

Clowse noted that DZP could be particularly beneficial for patients with SLE who want to get pregnant. Many drugs used to treat the disease are teratogenic; however, “because of the lack of Fc portion on this drug, it very likely does not cross the placenta in any kind of significant amount,” she said. Although there are not yet any reproductive safety data on DZP, she added, “that is a great potential niche.”

Biogen and UCB, which are jointly developing DZP, aim to start a second phase 3 trial of DZP in patients with SLE, called PHOENYCS FLY, in 2024.

The trial was sponsored by UCB. Clowse is a consultant and has received grant/research support from GSK and UCB. Gardner had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

WASHINGTON — The investigational anti-CD40 ligand agent dapirolizumab pegol (DZP) outperformed placebo in improving disease activity and reducing high-dose corticosteroid use in patients with systemic lupus erythematosus (SLE) in the phase 3 PHOENYCS GO trial.

“We really think that dapirolizumab pegol may represent a novel treatment for lupus, particularly given its broad immune modulatory effects,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She presented the study in a late-breaking poster session at the American College of Rheumatology (ACR) 2024 Annual Meeting.

There is a “huge unmet need” for drugs for lupus, Clowse told this news organization. Patients with SLE continue to have high disease burden, including ongoing symptoms often driven by inflammation. Corticosteroids are often the best medications to control disease activity, she said, but they can result in long-term toxicity.

 

What Makes DZP Unique?

Through CD40 ligand signaling, DZP has been shown to reduce B- and T-cell activation and to downregulate interferon pathways. Previous antibodies targeting the CD40 ligand have been associated with an increased risk for thromboembolic events. However, DZP lacks the Fc portion of the antibody, which can bind to platelets and cause clotting. Data from phase 1, 2, and 3 trials thus far do not show an elevated risk for these events, Clowse explained. In fact, safety signals were strong enough that patients with antiphospholipid antibodies — a key driver for blood clots in patients with SLE — were included in the trial.

In PHOENYCS GO, investigators enrolled 321 patients with moderate to severe SLE with persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medications such as antimalarials, corticosteroids, and immunosuppressants.

Patients were randomized 2:1 to receive intravenous DZP (24 mg/kg) plus SOC or intravenous placebo plus SOC every 4 weeks, with patients and investigators blinded to treatment assignments.

Patients taking a corticosteroid dose > 7.5 mg/day began a mandatory steroid taper by week 8 of the trial, with the goal of reducing that to < 7.5 mg/day. The tapering regimen was at the discretion of providers and was adapted to each patient’s individual disease activity.

The primary endpoint was British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response at week 48.

Patients in the DZP and placebo groups were on average 43.5 and 41.5 years old, respectively. More than 90% of patients were women, all on concomitant SLE medications. About half of the participants took a daily corticosteroid dose > 7.5 mg.

At 48 weeks, half of the DZP group (49.5%) achieved BICLA response compared with 34.6% in the placebo group (P = .0110). A higher proportion of patients taking DZP achieved SLE Responder Index-4 response than those taking placebo (60.1% vs 41.1%, respectively; P = .0014), and the rate of severe British Isles Lupus Assessment Group flares in the DZP group was half that of the placebo group (11.6% vs 23.4%; P = .0257). In the subgroup of patients who underwent corticosteroid tapering, 72.4% receiving DZP and 52.9% taking placebo reduced their dose to < 7.5 mg/day by 48 weeks (P = .0404).

DZP was generally well tolerated. Over 48 weeks, 82.6% of the DZP group and 75% of the placebo group reported treatment-emergent adverse events, but serious occurrences were more common in the placebo group (14.8%) than in the DZP group (9.9%). Herpes viral infections were higher in the placebo group, although there were three ophthalmic herpes cases in the DZP group. There was one case of acute myocardial infarction and one death linked to gangrene-related sepsis in patients receiving DZP.

 

A ‘Mild to Moderate’ Response

Although these are definitely positive results, they show a “mild to moderate response” to DZP, commented Gregory Gardner, MD, an emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, and chair of the American College of Rheumatology’s annual meeting planning committee. He moderated the session where the research was presented. Although DZP showed efficacy among some patients, he noted, “there were still 51% patients that it didn’t work for.” 

The drug uses an alternative pathway to current lupus drugs, Gardner added, and more research is needed to understand how best to use this medication in practice.

Clowse noted that DZP could be particularly beneficial for patients with SLE who want to get pregnant. Many drugs used to treat the disease are teratogenic; however, “because of the lack of Fc portion on this drug, it very likely does not cross the placenta in any kind of significant amount,” she said. Although there are not yet any reproductive safety data on DZP, she added, “that is a great potential niche.”

Biogen and UCB, which are jointly developing DZP, aim to start a second phase 3 trial of DZP in patients with SLE, called PHOENYCS FLY, in 2024.

The trial was sponsored by UCB. Clowse is a consultant and has received grant/research support from GSK and UCB. Gardner had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

WASHINGTON — The investigational anti-CD40 ligand agent dapirolizumab pegol (DZP) outperformed placebo in improving disease activity and reducing high-dose corticosteroid use in patients with systemic lupus erythematosus (SLE) in the phase 3 PHOENYCS GO trial.

“We really think that dapirolizumab pegol may represent a novel treatment for lupus, particularly given its broad immune modulatory effects,” said Megan Clowse, MD, MPH, associate professor of medicine and chief of the Division of Rheumatology and Immunology at Duke University School of Medicine in Durham, North Carolina. She presented the study in a late-breaking poster session at the American College of Rheumatology (ACR) 2024 Annual Meeting.

There is a “huge unmet need” for drugs for lupus, Clowse told this news organization. Patients with SLE continue to have high disease burden, including ongoing symptoms often driven by inflammation. Corticosteroids are often the best medications to control disease activity, she said, but they can result in long-term toxicity.

 

What Makes DZP Unique?

Through CD40 ligand signaling, DZP has been shown to reduce B- and T-cell activation and to downregulate interferon pathways. Previous antibodies targeting the CD40 ligand have been associated with an increased risk for thromboembolic events. However, DZP lacks the Fc portion of the antibody, which can bind to platelets and cause clotting. Data from phase 1, 2, and 3 trials thus far do not show an elevated risk for these events, Clowse explained. In fact, safety signals were strong enough that patients with antiphospholipid antibodies — a key driver for blood clots in patients with SLE — were included in the trial.

In PHOENYCS GO, investigators enrolled 321 patients with moderate to severe SLE with persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medications such as antimalarials, corticosteroids, and immunosuppressants.

Patients were randomized 2:1 to receive intravenous DZP (24 mg/kg) plus SOC or intravenous placebo plus SOC every 4 weeks, with patients and investigators blinded to treatment assignments.

Patients taking a corticosteroid dose > 7.5 mg/day began a mandatory steroid taper by week 8 of the trial, with the goal of reducing that to < 7.5 mg/day. The tapering regimen was at the discretion of providers and was adapted to each patient’s individual disease activity.

The primary endpoint was British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) response at week 48.

Patients in the DZP and placebo groups were on average 43.5 and 41.5 years old, respectively. More than 90% of patients were women, all on concomitant SLE medications. About half of the participants took a daily corticosteroid dose > 7.5 mg.

At 48 weeks, half of the DZP group (49.5%) achieved BICLA response compared with 34.6% in the placebo group (P = .0110). A higher proportion of patients taking DZP achieved SLE Responder Index-4 response than those taking placebo (60.1% vs 41.1%, respectively; P = .0014), and the rate of severe British Isles Lupus Assessment Group flares in the DZP group was half that of the placebo group (11.6% vs 23.4%; P = .0257). In the subgroup of patients who underwent corticosteroid tapering, 72.4% receiving DZP and 52.9% taking placebo reduced their dose to < 7.5 mg/day by 48 weeks (P = .0404).

DZP was generally well tolerated. Over 48 weeks, 82.6% of the DZP group and 75% of the placebo group reported treatment-emergent adverse events, but serious occurrences were more common in the placebo group (14.8%) than in the DZP group (9.9%). Herpes viral infections were higher in the placebo group, although there were three ophthalmic herpes cases in the DZP group. There was one case of acute myocardial infarction and one death linked to gangrene-related sepsis in patients receiving DZP.

 

A ‘Mild to Moderate’ Response

Although these are definitely positive results, they show a “mild to moderate response” to DZP, commented Gregory Gardner, MD, an emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, and chair of the American College of Rheumatology’s annual meeting planning committee. He moderated the session where the research was presented. Although DZP showed efficacy among some patients, he noted, “there were still 51% patients that it didn’t work for.” 

The drug uses an alternative pathway to current lupus drugs, Gardner added, and more research is needed to understand how best to use this medication in practice.

Clowse noted that DZP could be particularly beneficial for patients with SLE who want to get pregnant. Many drugs used to treat the disease are teratogenic; however, “because of the lack of Fc portion on this drug, it very likely does not cross the placenta in any kind of significant amount,” she said. Although there are not yet any reproductive safety data on DZP, she added, “that is a great potential niche.”

Biogen and UCB, which are jointly developing DZP, aim to start a second phase 3 trial of DZP in patients with SLE, called PHOENYCS FLY, in 2024.

The trial was sponsored by UCB. Clowse is a consultant and has received grant/research support from GSK and UCB. Gardner had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

In a nearly unanimous vote at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN), members approved a revision to gout remission criteria first established in 2016. The new version simplifies the definition in response to patient comments that the earlier version was redundant in some areas. 

The previous version was developed following deliberations by 49 clinicians and researchers with experience in gout. They settled on a definition of gout remission that included five criteria:

• Serum urate levels lower than 0.36 mmol/L measured at least twice over 12 months, with no intervening values of 0.36 mmol/L or higher
• No gout flares over 12 months
• No tophi
• Pain score due to gout < 2 at least twice over 12 months on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values ≥ 2
• Patient global assessment of gout disease activity < 2 on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values of ≥ 2.

Some participants reported that patients sometimes misattributed pain from other sources while using patient-reported outcomes (PROs). The argument for keeping PROs was that they are validated measures and endorsed by Outcome Measures in Rheumatology. Nevertheless, there was no direct patient involvement in the development of the 2016 criteria.

Researchers later interviewed 20 individuals with well-controlled gout to get their feedback on the 2016 criteria. Those individuals endorsed the existing criteria and did not suggest any new ones, but they suggested that the pain due to gout and the absence of gout flares were redundant measures. One said: “If you have no flare-ups, you’ve got no pain; it sort of answers itself.”

“That was a bit challenging for us because it wasn’t quite what we expected, but I think it did make us look again at the definition and think about whether we could simplify the definition further,” Nicola Dalbeth, MBChB, said during a presentation at G-CAN. Dalbeth is an academic rheumatologist at the University of Auckland, in New Zealand, who was also the lead author of the original criteria.

 

Simplified Version Created With Only Three Criteria

In response to these points, researchers produced a revised version with only three criteria, including the serum urate, absence of gout flares, and absence of subcutaneous tophi at the time of assessment.

To determine if the simplified criteria performed well, they compared the original and revised remission criteria in the context of the CARES trial, the Nottingham nurse-led trial, and randomized controlled trials in patients with gout that were conducted in New Zealand (here and here).

Dansoa Tabi-Amponsah, a PhD candidate at the University of Auckland, presented results of a study comparing the two versions in the Nottingham trial, which included 517 participants who received nurse-led or usual general practitioner care. The nurse-led care included education, regular follow-up and serum urate testing, individualized advice on gout flare management, and escalation of urate-lowering therapy with a treat-to-target strategy.

Both definitions demonstrated a link between the nurse-led strategy and increased rates of remission at year 1 and year 2, although the simplified definition found that more patients were in remission (17.6% vs 9.9% at year 1 and 42.7% vs 28.4% at year 2, both P < .001). “This is something we’ve seen across all of our analyses,” said Tabi-Amponsah. 

Both criteria also found significant differences in remission rates between the nurse-led group in year 2 vs year 1 but not in the usual care group.

Participants who achieved remission had better gout impact scale scores in areas like worrying that a gout attack will occur, fears of worsening gout, and concerns about the impact of gout on future activities. “This is important because during that qualitative study, a key aspect of being in remission was no longer being worried about their gout, no longer feeling anxious about having constant gout flares, and having control over their gout. So, it’s important to note that despite the absence of PROs in that simplified definition, it’s still able to align with the patients’ perspectives of their disease state,” said Tabi-Amponsah.

During the Q&A period after her talk, an audience member asked whether the higher rate of remission found by the simplified criteria is actually a good thing. “If I compare that to rheumatoid arthritis, when you use DAS28 you have a lot more remission, but still progression. So, are we missing some people? Are we including people in remission that still have disease?” she asked. 

Tabi-Amponsah responded that the pain and patient global assessment domains seem to be quite difficult to achieve. In a separate analysis, the researchers examined tender and swollen joint counts and found that those achieving remission no longer had tender or swollen joints. “So, we don’t think the simplified definition is heavily misclassifying anyone as being in remission,” she said. 

During the Q&A following Dalbeth’s talk, an audience member asked about patients with what he described as “mountains of tophi,” despite responding well to uricase therapy. “They may take months or even a year to really resolve that burden. They may be doing very well, yet they’re not going to be in remission because they’ve still got visible tophi. So, are we underselling them, and do we need a different definition for them doing well that this doesn’t capture?” he asked.

Dalbeth suggested that patients with large amounts of tophi aren’t really in remission. “I think we do need to be thinking about the disease, not just in terms of just crystals or just inflammation, but actually trying to integrate both of those, and I think this is where these composite measures might work quite well. I think we need to be aiming for holistic disease control, which is essentially what this is,” she said. 

Tabi-Amponsah and Dalbeth did not disclose any financial relationships. 

 

A version of this article appeared on Medscape.com.

In a nearly unanimous vote at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN), members approved a revision to gout remission criteria first established in 2016. The new version simplifies the definition in response to patient comments that the earlier version was redundant in some areas. 

The previous version was developed following deliberations by 49 clinicians and researchers with experience in gout. They settled on a definition of gout remission that included five criteria:

• Serum urate levels lower than 0.36 mmol/L measured at least twice over 12 months, with no intervening values of 0.36 mmol/L or higher
• No gout flares over 12 months
• No tophi
• Pain score due to gout < 2 at least twice over 12 months on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values ≥ 2
• Patient global assessment of gout disease activity < 2 on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values of ≥ 2.

Some participants reported that patients sometimes misattributed pain from other sources while using patient-reported outcomes (PROs). The argument for keeping PROs was that they are validated measures and endorsed by Outcome Measures in Rheumatology. Nevertheless, there was no direct patient involvement in the development of the 2016 criteria.

Researchers later interviewed 20 individuals with well-controlled gout to get their feedback on the 2016 criteria. Those individuals endorsed the existing criteria and did not suggest any new ones, but they suggested that the pain due to gout and the absence of gout flares were redundant measures. One said: “If you have no flare-ups, you’ve got no pain; it sort of answers itself.”

“That was a bit challenging for us because it wasn’t quite what we expected, but I think it did make us look again at the definition and think about whether we could simplify the definition further,” Nicola Dalbeth, MBChB, said during a presentation at G-CAN. Dalbeth is an academic rheumatologist at the University of Auckland, in New Zealand, who was also the lead author of the original criteria.

 

Simplified Version Created With Only Three Criteria

In response to these points, researchers produced a revised version with only three criteria, including the serum urate, absence of gout flares, and absence of subcutaneous tophi at the time of assessment.

To determine if the simplified criteria performed well, they compared the original and revised remission criteria in the context of the CARES trial, the Nottingham nurse-led trial, and randomized controlled trials in patients with gout that were conducted in New Zealand (here and here).

Dansoa Tabi-Amponsah, a PhD candidate at the University of Auckland, presented results of a study comparing the two versions in the Nottingham trial, which included 517 participants who received nurse-led or usual general practitioner care. The nurse-led care included education, regular follow-up and serum urate testing, individualized advice on gout flare management, and escalation of urate-lowering therapy with a treat-to-target strategy.

Both definitions demonstrated a link between the nurse-led strategy and increased rates of remission at year 1 and year 2, although the simplified definition found that more patients were in remission (17.6% vs 9.9% at year 1 and 42.7% vs 28.4% at year 2, both P < .001). “This is something we’ve seen across all of our analyses,” said Tabi-Amponsah. 

Both criteria also found significant differences in remission rates between the nurse-led group in year 2 vs year 1 but not in the usual care group.

Participants who achieved remission had better gout impact scale scores in areas like worrying that a gout attack will occur, fears of worsening gout, and concerns about the impact of gout on future activities. “This is important because during that qualitative study, a key aspect of being in remission was no longer being worried about their gout, no longer feeling anxious about having constant gout flares, and having control over their gout. So, it’s important to note that despite the absence of PROs in that simplified definition, it’s still able to align with the patients’ perspectives of their disease state,” said Tabi-Amponsah.

During the Q&A period after her talk, an audience member asked whether the higher rate of remission found by the simplified criteria is actually a good thing. “If I compare that to rheumatoid arthritis, when you use DAS28 you have a lot more remission, but still progression. So, are we missing some people? Are we including people in remission that still have disease?” she asked. 

Tabi-Amponsah responded that the pain and patient global assessment domains seem to be quite difficult to achieve. In a separate analysis, the researchers examined tender and swollen joint counts and found that those achieving remission no longer had tender or swollen joints. “So, we don’t think the simplified definition is heavily misclassifying anyone as being in remission,” she said. 

During the Q&A following Dalbeth’s talk, an audience member asked about patients with what he described as “mountains of tophi,” despite responding well to uricase therapy. “They may take months or even a year to really resolve that burden. They may be doing very well, yet they’re not going to be in remission because they’ve still got visible tophi. So, are we underselling them, and do we need a different definition for them doing well that this doesn’t capture?” he asked.

Dalbeth suggested that patients with large amounts of tophi aren’t really in remission. “I think we do need to be thinking about the disease, not just in terms of just crystals or just inflammation, but actually trying to integrate both of those, and I think this is where these composite measures might work quite well. I think we need to be aiming for holistic disease control, which is essentially what this is,” she said. 

Tabi-Amponsah and Dalbeth did not disclose any financial relationships. 

 

A version of this article appeared on Medscape.com.

In a nearly unanimous vote at the annual research symposium of the Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN), members approved a revision to gout remission criteria first established in 2016. The new version simplifies the definition in response to patient comments that the earlier version was redundant in some areas. 

The previous version was developed following deliberations by 49 clinicians and researchers with experience in gout. They settled on a definition of gout remission that included five criteria:

• Serum urate levels lower than 0.36 mmol/L measured at least twice over 12 months, with no intervening values of 0.36 mmol/L or higher
• No gout flares over 12 months
• No tophi
• Pain score due to gout < 2 at least twice over 12 months on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values ≥ 2
• Patient global assessment of gout disease activity < 2 on a 10-point Likert scale or 10-cm visual analog scale, with no intervening values of ≥ 2.

Some participants reported that patients sometimes misattributed pain from other sources while using patient-reported outcomes (PROs). The argument for keeping PROs was that they are validated measures and endorsed by Outcome Measures in Rheumatology. Nevertheless, there was no direct patient involvement in the development of the 2016 criteria.

Researchers later interviewed 20 individuals with well-controlled gout to get their feedback on the 2016 criteria. Those individuals endorsed the existing criteria and did not suggest any new ones, but they suggested that the pain due to gout and the absence of gout flares were redundant measures. One said: “If you have no flare-ups, you’ve got no pain; it sort of answers itself.”

“That was a bit challenging for us because it wasn’t quite what we expected, but I think it did make us look again at the definition and think about whether we could simplify the definition further,” Nicola Dalbeth, MBChB, said during a presentation at G-CAN. Dalbeth is an academic rheumatologist at the University of Auckland, in New Zealand, who was also the lead author of the original criteria.

 

Simplified Version Created With Only Three Criteria

In response to these points, researchers produced a revised version with only three criteria, including the serum urate, absence of gout flares, and absence of subcutaneous tophi at the time of assessment.

To determine if the simplified criteria performed well, they compared the original and revised remission criteria in the context of the CARES trial, the Nottingham nurse-led trial, and randomized controlled trials in patients with gout that were conducted in New Zealand (here and here).

Dansoa Tabi-Amponsah, a PhD candidate at the University of Auckland, presented results of a study comparing the two versions in the Nottingham trial, which included 517 participants who received nurse-led or usual general practitioner care. The nurse-led care included education, regular follow-up and serum urate testing, individualized advice on gout flare management, and escalation of urate-lowering therapy with a treat-to-target strategy.

Both definitions demonstrated a link between the nurse-led strategy and increased rates of remission at year 1 and year 2, although the simplified definition found that more patients were in remission (17.6% vs 9.9% at year 1 and 42.7% vs 28.4% at year 2, both P < .001). “This is something we’ve seen across all of our analyses,” said Tabi-Amponsah. 

Both criteria also found significant differences in remission rates between the nurse-led group in year 2 vs year 1 but not in the usual care group.

Participants who achieved remission had better gout impact scale scores in areas like worrying that a gout attack will occur, fears of worsening gout, and concerns about the impact of gout on future activities. “This is important because during that qualitative study, a key aspect of being in remission was no longer being worried about their gout, no longer feeling anxious about having constant gout flares, and having control over their gout. So, it’s important to note that despite the absence of PROs in that simplified definition, it’s still able to align with the patients’ perspectives of their disease state,” said Tabi-Amponsah.

During the Q&A period after her talk, an audience member asked whether the higher rate of remission found by the simplified criteria is actually a good thing. “If I compare that to rheumatoid arthritis, when you use DAS28 you have a lot more remission, but still progression. So, are we missing some people? Are we including people in remission that still have disease?” she asked. 

Tabi-Amponsah responded that the pain and patient global assessment domains seem to be quite difficult to achieve. In a separate analysis, the researchers examined tender and swollen joint counts and found that those achieving remission no longer had tender or swollen joints. “So, we don’t think the simplified definition is heavily misclassifying anyone as being in remission,” she said. 

During the Q&A following Dalbeth’s talk, an audience member asked about patients with what he described as “mountains of tophi,” despite responding well to uricase therapy. “They may take months or even a year to really resolve that burden. They may be doing very well, yet they’re not going to be in remission because they’ve still got visible tophi. So, are we underselling them, and do we need a different definition for them doing well that this doesn’t capture?” he asked.

Dalbeth suggested that patients with large amounts of tophi aren’t really in remission. “I think we do need to be thinking about the disease, not just in terms of just crystals or just inflammation, but actually trying to integrate both of those, and I think this is where these composite measures might work quite well. I think we need to be aiming for holistic disease control, which is essentially what this is,” she said. 

Tabi-Amponsah and Dalbeth did not disclose any financial relationships. 

 

A version of this article appeared on Medscape.com.