Rheumatology News

TOPLINE:

A higher intake of ultraprocessed foods increases the risk for systemic lupus erythematosus (SLE) by over 50% in women. The risk doubled in those with anti–double-stranded DNA antibodies.

METHODOLOGY:

• Researchers assessed 204,175 women from two Nurses’ Health Study cohorts from 1984 to 2016.
• Participants completed semiquantitative food frequency questionnaires every 4 years for the assessment of dietary intake.
• Incident SLE cases were self-reported and confirmed using medical records, with 212 cases identified.

TAKEAWAY:

• A higher cumulative average daily intake of ultraprocessed foods was associated with a 56% increased risk for SLE (95% confidence interval [CI], 1.04-2.32).
• The risk for anti–double-stranded DNA antibody-positive SLE was more than doubled (hazard ratio, 2.05; 95% CI, 1.15-3.65).
• Sugar or artificially sweetened beverages were associated with a 45% increased risk for SLE (95% CI, 1.01-2.09).
• No significant interactions with body mass index were observed in the association between ultraprocessed food intake and SLE.

IN PRACTICE:

This study is too preliminary to have practical application.

SOURCE:

The study was led by Sinara Rossato, PhD, Harvard T.H. Chan School of Public Health, Boston. It was published online in Arthritis Care & Research.

LIMITATIONS:

The study’s generalizability is limited due to the predominantly White female population of registered nurses. The relatively high baseline age of participants may not fully capture the peak incidence age range for SLE. The observational nature of the study cannot establish causality between ultraprocessed food intake and SLE risk.

DISCLOSURES:

The study was supported by the National Institutes of Health. The authors did not declare any competing interests.

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 first appeared on Medscape.com.

TOPLINE:

A higher intake of ultraprocessed foods increases the risk for systemic lupus erythematosus (SLE) by over 50% in women. The risk doubled in those with anti–double-stranded DNA antibodies.

METHODOLOGY:

• Researchers assessed 204,175 women from two Nurses’ Health Study cohorts from 1984 to 2016.
• Participants completed semiquantitative food frequency questionnaires every 4 years for the assessment of dietary intake.
• Incident SLE cases were self-reported and confirmed using medical records, with 212 cases identified.

TAKEAWAY:

• A higher cumulative average daily intake of ultraprocessed foods was associated with a 56% increased risk for SLE (95% confidence interval [CI], 1.04-2.32).
• The risk for anti–double-stranded DNA antibody-positive SLE was more than doubled (hazard ratio, 2.05; 95% CI, 1.15-3.65).
• Sugar or artificially sweetened beverages were associated with a 45% increased risk for SLE (95% CI, 1.01-2.09).
• No significant interactions with body mass index were observed in the association between ultraprocessed food intake and SLE.

IN PRACTICE:

This study is too preliminary to have practical application.

SOURCE:

The study was led by Sinara Rossato, PhD, Harvard T.H. Chan School of Public Health, Boston. It was published online in Arthritis Care & Research.

LIMITATIONS:

The study’s generalizability is limited due to the predominantly White female population of registered nurses. The relatively high baseline age of participants may not fully capture the peak incidence age range for SLE. The observational nature of the study cannot establish causality between ultraprocessed food intake and SLE risk.

DISCLOSURES:

The study was supported by the National Institutes of Health. The authors did not declare any competing interests.

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 first appeared on Medscape.com.

TOPLINE:

A higher intake of ultraprocessed foods increases the risk for systemic lupus erythematosus (SLE) by over 50% in women. The risk doubled in those with anti–double-stranded DNA antibodies.

METHODOLOGY:

• Researchers assessed 204,175 women from two Nurses’ Health Study cohorts from 1984 to 2016.
• Participants completed semiquantitative food frequency questionnaires every 4 years for the assessment of dietary intake.
• Incident SLE cases were self-reported and confirmed using medical records, with 212 cases identified.

TAKEAWAY:

• A higher cumulative average daily intake of ultraprocessed foods was associated with a 56% increased risk for SLE (95% confidence interval [CI], 1.04-2.32).
• The risk for anti–double-stranded DNA antibody-positive SLE was more than doubled (hazard ratio, 2.05; 95% CI, 1.15-3.65).
• Sugar or artificially sweetened beverages were associated with a 45% increased risk for SLE (95% CI, 1.01-2.09).
• No significant interactions with body mass index were observed in the association between ultraprocessed food intake and SLE.

IN PRACTICE:

This study is too preliminary to have practical application.

SOURCE:

The study was led by Sinara Rossato, PhD, Harvard T.H. Chan School of Public Health, Boston. It was published online in Arthritis Care & Research.

LIMITATIONS:

The study’s generalizability is limited due to the predominantly White female population of registered nurses. The relatively high baseline age of participants may not fully capture the peak incidence age range for SLE. The observational nature of the study cannot establish causality between ultraprocessed food intake and SLE risk.

DISCLOSURES:

The study was supported by the National Institutes of Health. The authors did not declare any competing interests.

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 first appeared on Medscape.com.

Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.

The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.

This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
 

1. Find Relocation Resources

First things first. Find out what your program or hospital has to offer.

Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.

Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.

Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.

When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.

If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
 

2. Reach Out and Buddy Up

Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.

Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.

On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.

Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.

To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
 

3. Play the ‘Doctor Card’

Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”

“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
 

4. Move Early

Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.

Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.

“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
 

5. Make Your New Home Your Sanctuary

During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.

Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”

Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.

“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
 

6. Consider a ‘Live’ Stress Reliever

When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.

Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”

Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.

Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”

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

Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.

The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.

This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
 

1. Find Relocation Resources

First things first. Find out what your program or hospital has to offer.

Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.

Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.

Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.

When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.

If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
 

2. Reach Out and Buddy Up

Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.

Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.

On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.

Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.

To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
 

3. Play the ‘Doctor Card’

Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”

“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
 

4. Move Early

Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.

Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.

“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
 

5. Make Your New Home Your Sanctuary

During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.

Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”

Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.

“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
 

6. Consider a ‘Live’ Stress Reliever

When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.

Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”

Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.

Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”

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

Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.

The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.

This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
 

1. Find Relocation Resources

First things first. Find out what your program or hospital has to offer.

Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.

Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.

Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.

When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.

If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
 

2. Reach Out and Buddy Up

Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.

Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.

On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.

Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.

To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
 

3. Play the ‘Doctor Card’

Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”

“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
 

4. Move Early

Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.

Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.

“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
 

5. Make Your New Home Your Sanctuary

During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.

Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”

Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.

“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
 

6. Consider a ‘Live’ Stress Reliever

When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.

Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”

Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.

Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”

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

More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.

These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.

This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.

Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
 

Tenuous Causal Link

While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.

Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.

“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
 

Institutions’ Role

Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”

The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
 

A Doctor’s Role

And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.

From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
 

Misinformation vs Disinformation

The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.

The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, 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.

More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.

These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.

This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.

Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
 

Tenuous Causal Link

While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.

Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.

“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
 

Institutions’ Role

Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”

The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
 

A Doctor’s Role

And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.

From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
 

Misinformation vs Disinformation

The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.

The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, 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.

More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.

These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.

This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.

Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
 

Tenuous Causal Link

While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.

Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.

“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
 

Institutions’ Role

Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”

The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
 

A Doctor’s Role

And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.

From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
 

Misinformation vs Disinformation

The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.

The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, 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:

Nearly half of patients with difficult-to-treat rheumatoid arthritis (D2T RA) no longer met the criteria for that status at the end of a 5-year period by achieving disease remission or low disease activity with additional treatment modifications.

METHODOLOGY:

• This retrospective cohort study included 150 patients with D2T RA, as defined by the European Alliance of Associations for Rheumatology, in 2018 at Keio University Hospital, Tokyo.
• The researchers followed patients until 2023 and collected data on demographics, treatment changes, disease activity, and outcomes.
• D2T RA resolution was defined as achieving remission or low disease activity for ≥ 3 consecutive months.

TAKEAWAY:

• Overall, 45% of patients achieved resolution of D2T RA at a mean duration of 24.1 months.
• Treatment changes were more frequent in patients with resolved disease vs those with persistent D2T RA (83.6% vs 58.7%; P = .002).
• Patients with resolved D2T RA were more frequently treated with interleukin-6 receptor inhibitors in 2023 vs 2018 (35.8% vs 20.0%; P = .04) and less often treated with prednisolone (14.9% vs 38.7%; P < .001).
• Over 5 years, 5% of the patients died; increased glucocorticoid doses were linked to mortality (P = .002).

IN PRACTICE:

“Although a treatment strategy for difficult-to-treat RA has not yet been established, our study suggests that the optimal treatment choice for patients with difficult-to-treat RA is distinct, based on the causes,” wrote the authors.

SOURCE:

The study was led by Satoshi Takanashi, MD, PhD, from Keio University School of Medicine in Tokyo. It was published online in Rheumatology.

LIMITATIONS:

The study’s single-center design and relatively small sample size may limit the generalizability of the findings. Treatment changes were decided by attending doctors, which could introduce bias. The investigators were also unable to determine the impact of any comorbid fibromyalgia in the patients.

DISCLOSURES:

The study was supported by the JCR Grant for Promoting Research for Difficult-to-Treat Rheumatoid Arthritis, a KAKENHI grant from the Japan Society for the Promotion of Science, and Keio University Medical Science Fund. Each of the study’s three authors reported financial relationships with various manufacturers of drugs for RA.

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:

Nearly half of patients with difficult-to-treat rheumatoid arthritis (D2T RA) no longer met the criteria for that status at the end of a 5-year period by achieving disease remission or low disease activity with additional treatment modifications.

METHODOLOGY:

• This retrospective cohort study included 150 patients with D2T RA, as defined by the European Alliance of Associations for Rheumatology, in 2018 at Keio University Hospital, Tokyo.
• The researchers followed patients until 2023 and collected data on demographics, treatment changes, disease activity, and outcomes.
• D2T RA resolution was defined as achieving remission or low disease activity for ≥ 3 consecutive months.

TAKEAWAY:

• Overall, 45% of patients achieved resolution of D2T RA at a mean duration of 24.1 months.
• Treatment changes were more frequent in patients with resolved disease vs those with persistent D2T RA (83.6% vs 58.7%; P = .002).
• Patients with resolved D2T RA were more frequently treated with interleukin-6 receptor inhibitors in 2023 vs 2018 (35.8% vs 20.0%; P = .04) and less often treated with prednisolone (14.9% vs 38.7%; P < .001).
• Over 5 years, 5% of the patients died; increased glucocorticoid doses were linked to mortality (P = .002).

IN PRACTICE:

“Although a treatment strategy for difficult-to-treat RA has not yet been established, our study suggests that the optimal treatment choice for patients with difficult-to-treat RA is distinct, based on the causes,” wrote the authors.

SOURCE:

The study was led by Satoshi Takanashi, MD, PhD, from Keio University School of Medicine in Tokyo. It was published online in Rheumatology.

LIMITATIONS:

The study’s single-center design and relatively small sample size may limit the generalizability of the findings. Treatment changes were decided by attending doctors, which could introduce bias. The investigators were also unable to determine the impact of any comorbid fibromyalgia in the patients.

DISCLOSURES:

The study was supported by the JCR Grant for Promoting Research for Difficult-to-Treat Rheumatoid Arthritis, a KAKENHI grant from the Japan Society for the Promotion of Science, and Keio University Medical Science Fund. Each of the study’s three authors reported financial relationships with various manufacturers of drugs for RA.

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:

Nearly half of patients with difficult-to-treat rheumatoid arthritis (D2T RA) no longer met the criteria for that status at the end of a 5-year period by achieving disease remission or low disease activity with additional treatment modifications.

METHODOLOGY:

• This retrospective cohort study included 150 patients with D2T RA, as defined by the European Alliance of Associations for Rheumatology, in 2018 at Keio University Hospital, Tokyo.
• The researchers followed patients until 2023 and collected data on demographics, treatment changes, disease activity, and outcomes.
• D2T RA resolution was defined as achieving remission or low disease activity for ≥ 3 consecutive months.

TAKEAWAY:

• Overall, 45% of patients achieved resolution of D2T RA at a mean duration of 24.1 months.
• Treatment changes were more frequent in patients with resolved disease vs those with persistent D2T RA (83.6% vs 58.7%; P = .002).
• Patients with resolved D2T RA were more frequently treated with interleukin-6 receptor inhibitors in 2023 vs 2018 (35.8% vs 20.0%; P = .04) and less often treated with prednisolone (14.9% vs 38.7%; P < .001).
• Over 5 years, 5% of the patients died; increased glucocorticoid doses were linked to mortality (P = .002).

IN PRACTICE:

“Although a treatment strategy for difficult-to-treat RA has not yet been established, our study suggests that the optimal treatment choice for patients with difficult-to-treat RA is distinct, based on the causes,” wrote the authors.

SOURCE:

The study was led by Satoshi Takanashi, MD, PhD, from Keio University School of Medicine in Tokyo. It was published online in Rheumatology.

LIMITATIONS:

The study’s single-center design and relatively small sample size may limit the generalizability of the findings. Treatment changes were decided by attending doctors, which could introduce bias. The investigators were also unable to determine the impact of any comorbid fibromyalgia in the patients.

DISCLOSURES:

The study was supported by the JCR Grant for Promoting Research for Difficult-to-Treat Rheumatoid Arthritis, a KAKENHI grant from the Japan Society for the Promotion of Science, and Keio University Medical Science Fund. Each of the study’s three authors reported financial relationships with various manufacturers of drugs for RA.

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.

VIENNA — Safe and effective options for lowering serum uric acid (sUA) in patients with gout who are refractory to conventional therapies appear to be near, judging from phase 2 and 3 trials that produced positive results at the annual European Congress of Rheumatology.

Reports from the meeting included two phase 2 studies with novel urate anion transporter 1 (URAT1) inhibitors for patients with refractory gout, in addition to extension data from the phase 3 trial program for SEL-212. In all cases, efficacy appeared to be on the same order of currently available drugs with potentially better tolerability, an important unmet need for patients with gout refractory to traditional therapies.
 

12-Month Outcomes With SEL-212

The extension data with SEL-212 follow the 6-month results presented from the DISSOLVE I and II trials at EULAR 2023. Now at 12 months, the benefits have proven to be generally sustained with no new safety signals, according to Herbert S.B. Baraf, MD, The Center for Rheumatology and Bone Research, Wheaton, Maryland.

Arthritis Foundation

SEL-212 is a drug platform involving two components delivered by intravenous infusion once monthly in sequence. The first, SEL-110, consists of tolerogenic nanoparticles containing sirolimus. The second, SEL-037, is the pegylated uricase pegadricase.

On the 1-month dosing schedule, most patients who had responded at 6 months were still responding at 12 months, and both of the two study doses of SEL-212 in the DISSOLVE trials were well tolerated over the extension, Dr. Baraf reported.

On the basis of the data so far, “this will be an effective and well tolerated therapy for refractory gout over a period of at least 12 months,” Dr. Baraf said.

The DISSOLVE I and II trials were identically designed. Patients with refractory gout, defined as failure to normalize sUA or control symptoms with a xanthine oxidase inhibitor, were randomly assigned to receive 0.15 mg SEL-212, 1.0 mg SEL-212, or placebo.

There was a stopping rule for patients who reached a sUA level < 2 mg/dL 1 hour after the infusion.

The primary endpoint was sUA level < 6 mg/dL for at least 80% of the sixth month of the 6-month trial. About 50% of patients on either dose of SEL-212 met this endpoint (vs 4% of those receiving placebo; P < .0001). There was a numerical advantage for the higher dose in both studies.

Patients who completed the 6-month trial were eligible for a 6-month extension, during which they remained on their assigned therapy, including placebo. This phase was also blinded. Patients who met the stopping rule in either the main study or extension did not take the study drug but remained in the study for final analysis.

Of the 265 patients who participated in the main phase of the study, 143 (54%) completed the 6-month extension. Most discontinuations were the result of the stopping rule. Reasons for other patients discontinuing the study included withdrawal of consent in about 10% of each treatment arm and adverse events in 13.8%, 6.8%, and 2.2% of the high-dose, low-dose, and placebo groups, respectively.

At 12 months, when the data from the two trials were pooled, the proportion of patients on therapy and responding remained at about 50% in the high-dose group and 43% in the low-dose group on an intention-to-treat analysis. Relative to the 8% response rate for placebo, the advantage for either dose was highly significant (P < .0001).

In the subgroup of patients with tophi at baseline, representing about half the study group, responses were low at 12 months, whether on high- (41%) or low-dose (43%) SEL-212. The rate of response among placebo patients with baseline tophi was 9%.
 

Safety of SEL-212

The safety over the 6-month extension did not differ substantially from that observed during the first 6 months, according to Dr. Baraf. This was reiterated in more detail by Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania. He delivered a separate safety presentation focused on DISSOLVE I.

Specifically, there were no serious adverse events thought to be related to treatment. Besides gout flares, which affected approximately 27% of patients regardless of active treatment or placebo assignment, the most common adverse effect was hypertriglyceridemia, which was observed in 5.4% of patients on active treatment vs 0% of those receiving placebo. Independent of the treatment arm, less than 5% of patients developed stomatitis or cellulitis during the 6-month extension period.

In the 6-month extension phase, there were no infusion reactions observed within 1 hour after SEL-212 administration and just two overall that occurred with low-dose SEL-212, according to Kivitz.

New Selective URAT1 Inhibitors

The other potential advance in the treatment of refractory gout is coming from newer selective URAT1 inhibitors. According to the lead investigators of two phase 2 trials evaluating a novel URAT1 inhibitor, the urate transporter protein has long been considered the most promising target for gout treatment. As this protein regulates the absorption of uric acid from the renal tubule, it has a direct uric acid–lowering effect. However, the adverse events of current agents, such as probenecid, benzbromarone, and sulfinpyrazone, have created a need for drugs with a better benefit-to-risk ratio.

In one of two multicenter phase 2 studies on refractory gout, the experimental agent ruzinurad was tested as an adjunct to the xanthine oxidase inhibitor febuxostat. In the other, the objective was to evaluate whether the experimental agent AR882 or AR882 plus allopurinol is better than allopurinol alone for reducing tophi at 12 months.
 

Ruzinurad Plus Febuxostat

In the ruzinurad trial, 151 patients with symptomatic gout and elevated sUA (> 6 mg/dL) for at least 6 weeks on stable doses of febuxostat were randomized to receive 5 mg ruzinurad, 10 mg ruzinurad, or placebo. All remained on febuxostat. In the active treatment arms, the starting ruzinurad dose was 1 mg before titrating up to the assigned target.

For the primary endpoint of sUA < 6 mg/dL at 12 weeks, the rates were 56.9%, 53.1%, and 13.7% in the high-dose, low-dose, and placebo groups, respectively (P < .0001 for both ruzinurad arms), reported Huihua Ding, MD, a clinician and researcher at Shanghai Jiao Tong University, Shanghai, China.

“Consistently, subgroup analyses based on baseline eGFR [estimated glomerular filtration rate], sUA, and tophus demonstrated superior effective of ruzinurad plus febuxostat over placebo plus febuxostat,” reported Dr. Ding, who noted that previous clinical studies suggested the potential for synergism between ruzinurad and febuxostat.

The proportion of patients achieving the more rigorous target of < 0.5 mg/dL was also higher with the higher and lower doses of ruzinurad vs placebo (43.1% and 38.8% vs 9.8%, respectively).

The proportion of patients with treatment-emergent side effects did not differ between the three groups. The most common were gout flares, which were observed in 39.2%, 49.0%, and 45.1% in the high-dose, low-dose, and placebo groups, respectively. Most adverse events were mild or moderate, and none led to treatment discontinuation.

The favorable benefit-to-risk profile of ruzinurad was attributed by Dr. Ding to its high relative selectivity and potent inhibition of URAT1, an advantage that might be relevant to avoiding side effects at higher doses.

AR882 in Patients With Tophi

In the trial with AR882, 42 patients with refractory gout and at least one subcutaneous tophus were randomized to receive 75 mg AR882, 50 mg AR882 plus allopurinol, or allopurinol alone. All drugs were taken once daily. Doses of allopurinol of up to 300 mg were permitted.

The changes in the target tophus area and crystal volume at month 6 were compared, and patients who completed this phase were invited into a 6-month extension. In the 6-month extension, 75 mg AR882 was additionally provided to those who had been in the single-agent allopurinol arm. The other arms were unchanged.

Tophi measurements were performed with calipers at regular intervals. Change from baseline in sUA levels was also an efficacy measure, according to Robert Keenan, MD, chief medical officer of Arthrosi Therapeutics, which is developing AR882.

From average baseline sUA levels of > 9 mg/dL, all three treatments reduced sUA levels by an average of at least 4.5 mg by month 3. At month 6, complete resolution of at least one target tophus was observed in 29% of the group randomized to receive 75 mg AR882 alone, 8% of those randomized to receive 50 mg AR882 plus allopurinol, and 8% of those on allopurinol alone.

At month 12, the average sUA levels were 4.3 mg/dL for 75 mg AR882, 3.7 mg/dL for 50 mg AR882 plus allopurinol, and 2.9 mg/dL for the 75 mg AR882 plus allopurinol extension-switch arm.

At the 12-month mark, the proportions of patients with complete resolution of any tophus were 50.0% for 75 mg AR882, 12.5% for 50 mg AR882 plus allopurinol, and 36.4% for the 75 mg AR882 plus allopurinol extension-switch arm, according to Dr. Keenan.

Compared with allopurinol alone at 6 months, 75 mg AR882 led to a reduction in total urate crystal volume, and this reduction was sustained at 12 months, he added.

Alone or in combination with allopurinol, AR882 was well tolerated. Gout flares were the most common adverse events, but they declined with continued AR882 treatment, according to Dr. Keenan. Diarrhea, headache, and upper respiratory infections were reported but were of mild or moderate severity.

Again, the take-home message from this study, like the other phase 2 study of a novel URAT1 inhibitor, is that these newer drugs might offer a better benefit-to-risk ratio, particularly in those with refractory disease.

“AR882 may offer improved efficacy and better safety compared to existing therapies in the treatment of patients with gout, including those with both clinically visible and subclinical crystal deposition,” Dr. Keenan said.

Dr. Baraf reported financial relationships with Horizon Therapeutics, Fresenius Kabi, Grünenthal, Olatec, Selecta Biosciences, and Sobi, which provided funding for the trials he discussed. Dr. Kivitz also reported a financial relationship with Sobi, which funded the DISSOLVE trials, along with AbbVie, Amgen, Eli Lilly, Flexion, GlaxoSmithKline, and Sanofi Regeneron. Dr. Ding reported no potential conflicts. The study she discussed was funded by Jiangsu Hengrui Pharmaceuticals. Dr. Keenan is an employee of Arthrosi Therapeutics, which provided funding for the trial he presented.

August 1, 2024 — Editor's note: This article has been updated to reflect the correct number of infusion reactions reported in the 6-month extension phase of the DISSOLVE I trial.

A version of this article appeared on Medscape.com.

VIENNA — Safe and effective options for lowering serum uric acid (sUA) in patients with gout who are refractory to conventional therapies appear to be near, judging from phase 2 and 3 trials that produced positive results at the annual European Congress of Rheumatology.

Reports from the meeting included two phase 2 studies with novel urate anion transporter 1 (URAT1) inhibitors for patients with refractory gout, in addition to extension data from the phase 3 trial program for SEL-212. In all cases, efficacy appeared to be on the same order of currently available drugs with potentially better tolerability, an important unmet need for patients with gout refractory to traditional therapies.
 

12-Month Outcomes With SEL-212

The extension data with SEL-212 follow the 6-month results presented from the DISSOLVE I and II trials at EULAR 2023. Now at 12 months, the benefits have proven to be generally sustained with no new safety signals, according to Herbert S.B. Baraf, MD, The Center for Rheumatology and Bone Research, Wheaton, Maryland.

Arthritis Foundation

SEL-212 is a drug platform involving two components delivered by intravenous infusion once monthly in sequence. The first, SEL-110, consists of tolerogenic nanoparticles containing sirolimus. The second, SEL-037, is the pegylated uricase pegadricase.

On the 1-month dosing schedule, most patients who had responded at 6 months were still responding at 12 months, and both of the two study doses of SEL-212 in the DISSOLVE trials were well tolerated over the extension, Dr. Baraf reported.

On the basis of the data so far, “this will be an effective and well tolerated therapy for refractory gout over a period of at least 12 months,” Dr. Baraf said.

The DISSOLVE I and II trials were identically designed. Patients with refractory gout, defined as failure to normalize sUA or control symptoms with a xanthine oxidase inhibitor, were randomly assigned to receive 0.15 mg SEL-212, 1.0 mg SEL-212, or placebo.

There was a stopping rule for patients who reached a sUA level < 2 mg/dL 1 hour after the infusion.

The primary endpoint was sUA level < 6 mg/dL for at least 80% of the sixth month of the 6-month trial. About 50% of patients on either dose of SEL-212 met this endpoint (vs 4% of those receiving placebo; P < .0001). There was a numerical advantage for the higher dose in both studies.

Patients who completed the 6-month trial were eligible for a 6-month extension, during which they remained on their assigned therapy, including placebo. This phase was also blinded. Patients who met the stopping rule in either the main study or extension did not take the study drug but remained in the study for final analysis.

Of the 265 patients who participated in the main phase of the study, 143 (54%) completed the 6-month extension. Most discontinuations were the result of the stopping rule. Reasons for other patients discontinuing the study included withdrawal of consent in about 10% of each treatment arm and adverse events in 13.8%, 6.8%, and 2.2% of the high-dose, low-dose, and placebo groups, respectively.

At 12 months, when the data from the two trials were pooled, the proportion of patients on therapy and responding remained at about 50% in the high-dose group and 43% in the low-dose group on an intention-to-treat analysis. Relative to the 8% response rate for placebo, the advantage for either dose was highly significant (P < .0001).

In the subgroup of patients with tophi at baseline, representing about half the study group, responses were low at 12 months, whether on high- (41%) or low-dose (43%) SEL-212. The rate of response among placebo patients with baseline tophi was 9%.
 

Safety of SEL-212

The safety over the 6-month extension did not differ substantially from that observed during the first 6 months, according to Dr. Baraf. This was reiterated in more detail by Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania. He delivered a separate safety presentation focused on DISSOLVE I.

Specifically, there were no serious adverse events thought to be related to treatment. Besides gout flares, which affected approximately 27% of patients regardless of active treatment or placebo assignment, the most common adverse effect was hypertriglyceridemia, which was observed in 5.4% of patients on active treatment vs 0% of those receiving placebo. Independent of the treatment arm, less than 5% of patients developed stomatitis or cellulitis during the 6-month extension period.

In the 6-month extension phase, there were no infusion reactions observed within 1 hour after SEL-212 administration and just two overall that occurred with low-dose SEL-212, according to Kivitz.

New Selective URAT1 Inhibitors

The other potential advance in the treatment of refractory gout is coming from newer selective URAT1 inhibitors. According to the lead investigators of two phase 2 trials evaluating a novel URAT1 inhibitor, the urate transporter protein has long been considered the most promising target for gout treatment. As this protein regulates the absorption of uric acid from the renal tubule, it has a direct uric acid–lowering effect. However, the adverse events of current agents, such as probenecid, benzbromarone, and sulfinpyrazone, have created a need for drugs with a better benefit-to-risk ratio.

In one of two multicenter phase 2 studies on refractory gout, the experimental agent ruzinurad was tested as an adjunct to the xanthine oxidase inhibitor febuxostat. In the other, the objective was to evaluate whether the experimental agent AR882 or AR882 plus allopurinol is better than allopurinol alone for reducing tophi at 12 months.
 

Ruzinurad Plus Febuxostat

In the ruzinurad trial, 151 patients with symptomatic gout and elevated sUA (> 6 mg/dL) for at least 6 weeks on stable doses of febuxostat were randomized to receive 5 mg ruzinurad, 10 mg ruzinurad, or placebo. All remained on febuxostat. In the active treatment arms, the starting ruzinurad dose was 1 mg before titrating up to the assigned target.

For the primary endpoint of sUA < 6 mg/dL at 12 weeks, the rates were 56.9%, 53.1%, and 13.7% in the high-dose, low-dose, and placebo groups, respectively (P < .0001 for both ruzinurad arms), reported Huihua Ding, MD, a clinician and researcher at Shanghai Jiao Tong University, Shanghai, China.

“Consistently, subgroup analyses based on baseline eGFR [estimated glomerular filtration rate], sUA, and tophus demonstrated superior effective of ruzinurad plus febuxostat over placebo plus febuxostat,” reported Dr. Ding, who noted that previous clinical studies suggested the potential for synergism between ruzinurad and febuxostat.

The proportion of patients achieving the more rigorous target of < 0.5 mg/dL was also higher with the higher and lower doses of ruzinurad vs placebo (43.1% and 38.8% vs 9.8%, respectively).

The proportion of patients with treatment-emergent side effects did not differ between the three groups. The most common were gout flares, which were observed in 39.2%, 49.0%, and 45.1% in the high-dose, low-dose, and placebo groups, respectively. Most adverse events were mild or moderate, and none led to treatment discontinuation.

The favorable benefit-to-risk profile of ruzinurad was attributed by Dr. Ding to its high relative selectivity and potent inhibition of URAT1, an advantage that might be relevant to avoiding side effects at higher doses.

AR882 in Patients With Tophi

In the trial with AR882, 42 patients with refractory gout and at least one subcutaneous tophus were randomized to receive 75 mg AR882, 50 mg AR882 plus allopurinol, or allopurinol alone. All drugs were taken once daily. Doses of allopurinol of up to 300 mg were permitted.

The changes in the target tophus area and crystal volume at month 6 were compared, and patients who completed this phase were invited into a 6-month extension. In the 6-month extension, 75 mg AR882 was additionally provided to those who had been in the single-agent allopurinol arm. The other arms were unchanged.

Tophi measurements were performed with calipers at regular intervals. Change from baseline in sUA levels was also an efficacy measure, according to Robert Keenan, MD, chief medical officer of Arthrosi Therapeutics, which is developing AR882.

From average baseline sUA levels of > 9 mg/dL, all three treatments reduced sUA levels by an average of at least 4.5 mg by month 3. At month 6, complete resolution of at least one target tophus was observed in 29% of the group randomized to receive 75 mg AR882 alone, 8% of those randomized to receive 50 mg AR882 plus allopurinol, and 8% of those on allopurinol alone.

At month 12, the average sUA levels were 4.3 mg/dL for 75 mg AR882, 3.7 mg/dL for 50 mg AR882 plus allopurinol, and 2.9 mg/dL for the 75 mg AR882 plus allopurinol extension-switch arm.

At the 12-month mark, the proportions of patients with complete resolution of any tophus were 50.0% for 75 mg AR882, 12.5% for 50 mg AR882 plus allopurinol, and 36.4% for the 75 mg AR882 plus allopurinol extension-switch arm, according to Dr. Keenan.

Compared with allopurinol alone at 6 months, 75 mg AR882 led to a reduction in total urate crystal volume, and this reduction was sustained at 12 months, he added.

Alone or in combination with allopurinol, AR882 was well tolerated. Gout flares were the most common adverse events, but they declined with continued AR882 treatment, according to Dr. Keenan. Diarrhea, headache, and upper respiratory infections were reported but were of mild or moderate severity.

Again, the take-home message from this study, like the other phase 2 study of a novel URAT1 inhibitor, is that these newer drugs might offer a better benefit-to-risk ratio, particularly in those with refractory disease.

“AR882 may offer improved efficacy and better safety compared to existing therapies in the treatment of patients with gout, including those with both clinically visible and subclinical crystal deposition,” Dr. Keenan said.

Dr. Baraf reported financial relationships with Horizon Therapeutics, Fresenius Kabi, Grünenthal, Olatec, Selecta Biosciences, and Sobi, which provided funding for the trials he discussed. Dr. Kivitz also reported a financial relationship with Sobi, which funded the DISSOLVE trials, along with AbbVie, Amgen, Eli Lilly, Flexion, GlaxoSmithKline, and Sanofi Regeneron. Dr. Ding reported no potential conflicts. The study she discussed was funded by Jiangsu Hengrui Pharmaceuticals. Dr. Keenan is an employee of Arthrosi Therapeutics, which provided funding for the trial he presented.

August 1, 2024 — Editor's note: This article has been updated to reflect the correct number of infusion reactions reported in the 6-month extension phase of the DISSOLVE I trial.

A version of this article appeared on Medscape.com.

VIENNA — Safe and effective options for lowering serum uric acid (sUA) in patients with gout who are refractory to conventional therapies appear to be near, judging from phase 2 and 3 trials that produced positive results at the annual European Congress of Rheumatology.

Reports from the meeting included two phase 2 studies with novel urate anion transporter 1 (URAT1) inhibitors for patients with refractory gout, in addition to extension data from the phase 3 trial program for SEL-212. In all cases, efficacy appeared to be on the same order of currently available drugs with potentially better tolerability, an important unmet need for patients with gout refractory to traditional therapies.
 

12-Month Outcomes With SEL-212

The extension data with SEL-212 follow the 6-month results presented from the DISSOLVE I and II trials at EULAR 2023. Now at 12 months, the benefits have proven to be generally sustained with no new safety signals, according to Herbert S.B. Baraf, MD, The Center for Rheumatology and Bone Research, Wheaton, Maryland.

Arthritis Foundation

SEL-212 is a drug platform involving two components delivered by intravenous infusion once monthly in sequence. The first, SEL-110, consists of tolerogenic nanoparticles containing sirolimus. The second, SEL-037, is the pegylated uricase pegadricase.

On the 1-month dosing schedule, most patients who had responded at 6 months were still responding at 12 months, and both of the two study doses of SEL-212 in the DISSOLVE trials were well tolerated over the extension, Dr. Baraf reported.

On the basis of the data so far, “this will be an effective and well tolerated therapy for refractory gout over a period of at least 12 months,” Dr. Baraf said.

The DISSOLVE I and II trials were identically designed. Patients with refractory gout, defined as failure to normalize sUA or control symptoms with a xanthine oxidase inhibitor, were randomly assigned to receive 0.15 mg SEL-212, 1.0 mg SEL-212, or placebo.

There was a stopping rule for patients who reached a sUA level < 2 mg/dL 1 hour after the infusion.

The primary endpoint was sUA level < 6 mg/dL for at least 80% of the sixth month of the 6-month trial. About 50% of patients on either dose of SEL-212 met this endpoint (vs 4% of those receiving placebo; P < .0001). There was a numerical advantage for the higher dose in both studies.

Patients who completed the 6-month trial were eligible for a 6-month extension, during which they remained on their assigned therapy, including placebo. This phase was also blinded. Patients who met the stopping rule in either the main study or extension did not take the study drug but remained in the study for final analysis.

Of the 265 patients who participated in the main phase of the study, 143 (54%) completed the 6-month extension. Most discontinuations were the result of the stopping rule. Reasons for other patients discontinuing the study included withdrawal of consent in about 10% of each treatment arm and adverse events in 13.8%, 6.8%, and 2.2% of the high-dose, low-dose, and placebo groups, respectively.

At 12 months, when the data from the two trials were pooled, the proportion of patients on therapy and responding remained at about 50% in the high-dose group and 43% in the low-dose group on an intention-to-treat analysis. Relative to the 8% response rate for placebo, the advantage for either dose was highly significant (P < .0001).

In the subgroup of patients with tophi at baseline, representing about half the study group, responses were low at 12 months, whether on high- (41%) or low-dose (43%) SEL-212. The rate of response among placebo patients with baseline tophi was 9%.
 

Safety of SEL-212

The safety over the 6-month extension did not differ substantially from that observed during the first 6 months, according to Dr. Baraf. This was reiterated in more detail by Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania. He delivered a separate safety presentation focused on DISSOLVE I.

Specifically, there were no serious adverse events thought to be related to treatment. Besides gout flares, which affected approximately 27% of patients regardless of active treatment or placebo assignment, the most common adverse effect was hypertriglyceridemia, which was observed in 5.4% of patients on active treatment vs 0% of those receiving placebo. Independent of the treatment arm, less than 5% of patients developed stomatitis or cellulitis during the 6-month extension period.

In the 6-month extension phase, there were no infusion reactions observed within 1 hour after SEL-212 administration and just two overall that occurred with low-dose SEL-212, according to Kivitz.

New Selective URAT1 Inhibitors

The other potential advance in the treatment of refractory gout is coming from newer selective URAT1 inhibitors. According to the lead investigators of two phase 2 trials evaluating a novel URAT1 inhibitor, the urate transporter protein has long been considered the most promising target for gout treatment. As this protein regulates the absorption of uric acid from the renal tubule, it has a direct uric acid–lowering effect. However, the adverse events of current agents, such as probenecid, benzbromarone, and sulfinpyrazone, have created a need for drugs with a better benefit-to-risk ratio.

In one of two multicenter phase 2 studies on refractory gout, the experimental agent ruzinurad was tested as an adjunct to the xanthine oxidase inhibitor febuxostat. In the other, the objective was to evaluate whether the experimental agent AR882 or AR882 plus allopurinol is better than allopurinol alone for reducing tophi at 12 months.
 

Ruzinurad Plus Febuxostat

In the ruzinurad trial, 151 patients with symptomatic gout and elevated sUA (> 6 mg/dL) for at least 6 weeks on stable doses of febuxostat were randomized to receive 5 mg ruzinurad, 10 mg ruzinurad, or placebo. All remained on febuxostat. In the active treatment arms, the starting ruzinurad dose was 1 mg before titrating up to the assigned target.

For the primary endpoint of sUA < 6 mg/dL at 12 weeks, the rates were 56.9%, 53.1%, and 13.7% in the high-dose, low-dose, and placebo groups, respectively (P < .0001 for both ruzinurad arms), reported Huihua Ding, MD, a clinician and researcher at Shanghai Jiao Tong University, Shanghai, China.

“Consistently, subgroup analyses based on baseline eGFR [estimated glomerular filtration rate], sUA, and tophus demonstrated superior effective of ruzinurad plus febuxostat over placebo plus febuxostat,” reported Dr. Ding, who noted that previous clinical studies suggested the potential for synergism between ruzinurad and febuxostat.

The proportion of patients achieving the more rigorous target of < 0.5 mg/dL was also higher with the higher and lower doses of ruzinurad vs placebo (43.1% and 38.8% vs 9.8%, respectively).

The proportion of patients with treatment-emergent side effects did not differ between the three groups. The most common were gout flares, which were observed in 39.2%, 49.0%, and 45.1% in the high-dose, low-dose, and placebo groups, respectively. Most adverse events were mild or moderate, and none led to treatment discontinuation.

The favorable benefit-to-risk profile of ruzinurad was attributed by Dr. Ding to its high relative selectivity and potent inhibition of URAT1, an advantage that might be relevant to avoiding side effects at higher doses.

AR882 in Patients With Tophi

In the trial with AR882, 42 patients with refractory gout and at least one subcutaneous tophus were randomized to receive 75 mg AR882, 50 mg AR882 plus allopurinol, or allopurinol alone. All drugs were taken once daily. Doses of allopurinol of up to 300 mg were permitted.

The changes in the target tophus area and crystal volume at month 6 were compared, and patients who completed this phase were invited into a 6-month extension. In the 6-month extension, 75 mg AR882 was additionally provided to those who had been in the single-agent allopurinol arm. The other arms were unchanged.

Tophi measurements were performed with calipers at regular intervals. Change from baseline in sUA levels was also an efficacy measure, according to Robert Keenan, MD, chief medical officer of Arthrosi Therapeutics, which is developing AR882.

From average baseline sUA levels of > 9 mg/dL, all three treatments reduced sUA levels by an average of at least 4.5 mg by month 3. At month 6, complete resolution of at least one target tophus was observed in 29% of the group randomized to receive 75 mg AR882 alone, 8% of those randomized to receive 50 mg AR882 plus allopurinol, and 8% of those on allopurinol alone.

At month 12, the average sUA levels were 4.3 mg/dL for 75 mg AR882, 3.7 mg/dL for 50 mg AR882 plus allopurinol, and 2.9 mg/dL for the 75 mg AR882 plus allopurinol extension-switch arm.

At the 12-month mark, the proportions of patients with complete resolution of any tophus were 50.0% for 75 mg AR882, 12.5% for 50 mg AR882 plus allopurinol, and 36.4% for the 75 mg AR882 plus allopurinol extension-switch arm, according to Dr. Keenan.

Compared with allopurinol alone at 6 months, 75 mg AR882 led to a reduction in total urate crystal volume, and this reduction was sustained at 12 months, he added.

Alone or in combination with allopurinol, AR882 was well tolerated. Gout flares were the most common adverse events, but they declined with continued AR882 treatment, according to Dr. Keenan. Diarrhea, headache, and upper respiratory infections were reported but were of mild or moderate severity.

Again, the take-home message from this study, like the other phase 2 study of a novel URAT1 inhibitor, is that these newer drugs might offer a better benefit-to-risk ratio, particularly in those with refractory disease.

“AR882 may offer improved efficacy and better safety compared to existing therapies in the treatment of patients with gout, including those with both clinically visible and subclinical crystal deposition,” Dr. Keenan said.

Dr. Baraf reported financial relationships with Horizon Therapeutics, Fresenius Kabi, Grünenthal, Olatec, Selecta Biosciences, and Sobi, which provided funding for the trials he discussed. Dr. Kivitz also reported a financial relationship with Sobi, which funded the DISSOLVE trials, along with AbbVie, Amgen, Eli Lilly, Flexion, GlaxoSmithKline, and Sanofi Regeneron. Dr. Ding reported no potential conflicts. The study she discussed was funded by Jiangsu Hengrui Pharmaceuticals. Dr. Keenan is an employee of Arthrosi Therapeutics, which provided funding for the trial he presented.

August 1, 2024 — Editor's note: This article has been updated to reflect the correct number of infusion reactions reported in the 6-month extension phase of the DISSOLVE I trial.

A version of this article appeared on Medscape.com.

TOPLINE:

A threshold of sustained lupus low disease activity state (LLDAS) or remission for 3 months significantly reduces the risk for damage accrual and flares in patients with systemic lupus erythematosus (SLE), with longer durations offering even greater protection. 

METHODOLOGY:

• This large, prospective, multicenter study aimed to quantify the impact of sustained LLDAS on irreversible damage and flares.
• It included 3449 patients (age, ≥ 18 years; 92.2% women) with SLE from 25 centers across 12 countries, analyzing a total of 37,662 visits.
• Sustained LLDAS or remission was defined as at least two consecutive visits over > 3 months in the respective state.
• The primary outcome measured was the accrual of irreversible organ damage, with flares as a key secondary outcome.

TAKEAWAY:

• During a median follow-up of 2.8 years, 80.2% of patients achieved LLDAS at least once, with 72.7% experiencing at least one episode of sustained LLDAS.
• Sustained LLDAS for > 3 months was linked to a reduced risk for damage accrual (hazard ratio [HR], 0.60; P < .0001).
• Protection from flares also increased with all durations of sustained LLDAS > 3 months (> 3 months: HR, 0.56; P < .0001; > 36 months: HR, 0.17; P < .0001).
• Longer periods of sustained LLDAS or remission were associated with significantly higher degrees of protection.

IN PRACTICE:

“These findings support the use of these treat-to-target endpoints in clinical practice and provide a practical target to aim for in SLE treatment,” the authors wrote. 

SOURCE:

The study was led by Vera Golder, MBBS, Monash University, Clayton, Australia. It was published online in The Lancet Rheumatology. 

LIMITATIONS:

While the study’s large scale and multinational cohort provided robust data, its observational design limited the ability to establish causality. The predominance of Asian ethnicity among the participants may have affected the generalizability of the findings to other populations. Additionally, the median follow-up duration of 2.8 years might not have captured long-term outcomes.

DISCLOSURES:

Some authors declared receiving grants, consulting fees, payments, and honoraria and having other ties with various sources. 

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:

A threshold of sustained lupus low disease activity state (LLDAS) or remission for 3 months significantly reduces the risk for damage accrual and flares in patients with systemic lupus erythematosus (SLE), with longer durations offering even greater protection. 

METHODOLOGY:

• This large, prospective, multicenter study aimed to quantify the impact of sustained LLDAS on irreversible damage and flares.
• It included 3449 patients (age, ≥ 18 years; 92.2% women) with SLE from 25 centers across 12 countries, analyzing a total of 37,662 visits.
• Sustained LLDAS or remission was defined as at least two consecutive visits over > 3 months in the respective state.
• The primary outcome measured was the accrual of irreversible organ damage, with flares as a key secondary outcome.

TAKEAWAY:

• During a median follow-up of 2.8 years, 80.2% of patients achieved LLDAS at least once, with 72.7% experiencing at least one episode of sustained LLDAS.
• Sustained LLDAS for > 3 months was linked to a reduced risk for damage accrual (hazard ratio [HR], 0.60; P < .0001).
• Protection from flares also increased with all durations of sustained LLDAS > 3 months (> 3 months: HR, 0.56; P < .0001; > 36 months: HR, 0.17; P < .0001).
• Longer periods of sustained LLDAS or remission were associated with significantly higher degrees of protection.

IN PRACTICE:

“These findings support the use of these treat-to-target endpoints in clinical practice and provide a practical target to aim for in SLE treatment,” the authors wrote. 

SOURCE:

The study was led by Vera Golder, MBBS, Monash University, Clayton, Australia. It was published online in The Lancet Rheumatology. 

LIMITATIONS:

While the study’s large scale and multinational cohort provided robust data, its observational design limited the ability to establish causality. The predominance of Asian ethnicity among the participants may have affected the generalizability of the findings to other populations. Additionally, the median follow-up duration of 2.8 years might not have captured long-term outcomes.

DISCLOSURES:

Some authors declared receiving grants, consulting fees, payments, and honoraria and having other ties with various sources. 

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:

A threshold of sustained lupus low disease activity state (LLDAS) or remission for 3 months significantly reduces the risk for damage accrual and flares in patients with systemic lupus erythematosus (SLE), with longer durations offering even greater protection. 

METHODOLOGY:

• This large, prospective, multicenter study aimed to quantify the impact of sustained LLDAS on irreversible damage and flares.
• It included 3449 patients (age, ≥ 18 years; 92.2% women) with SLE from 25 centers across 12 countries, analyzing a total of 37,662 visits.
• Sustained LLDAS or remission was defined as at least two consecutive visits over > 3 months in the respective state.
• The primary outcome measured was the accrual of irreversible organ damage, with flares as a key secondary outcome.

TAKEAWAY:

• During a median follow-up of 2.8 years, 80.2% of patients achieved LLDAS at least once, with 72.7% experiencing at least one episode of sustained LLDAS.
• Sustained LLDAS for > 3 months was linked to a reduced risk for damage accrual (hazard ratio [HR], 0.60; P < .0001).
• Protection from flares also increased with all durations of sustained LLDAS > 3 months (> 3 months: HR, 0.56; P < .0001; > 36 months: HR, 0.17; P < .0001).
• Longer periods of sustained LLDAS or remission were associated with significantly higher degrees of protection.

IN PRACTICE:

“These findings support the use of these treat-to-target endpoints in clinical practice and provide a practical target to aim for in SLE treatment,” the authors wrote. 

SOURCE:

The study was led by Vera Golder, MBBS, Monash University, Clayton, Australia. It was published online in The Lancet Rheumatology. 

LIMITATIONS:

While the study’s large scale and multinational cohort provided robust data, its observational design limited the ability to establish causality. The predominance of Asian ethnicity among the participants may have affected the generalizability of the findings to other populations. Additionally, the median follow-up duration of 2.8 years might not have captured long-term outcomes.

DISCLOSURES:

Some authors declared receiving grants, consulting fees, payments, and honoraria and having other ties with various sources. 

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.

VIENNA — From a dozen or so studies and sessions devoted to the role of chimeric antigen receptor (CAR) T cells in rheumatic diseases at the annual European Congress of Rheumatology, the message was uniformly positive, supporting growing evidence that drugs in this class are heading toward a paradigm shift in refractory rheumatic diseases.

Of the reports, an update from a 15-patient case series with at least 1 year of follow-up provides “the first long-term evidence of safety and efficacy in multiple rheumatic diseases,” according to Georg Schett, MD, PhD, director of rheumatology and immunology, University of Erlangen-Nürnberg, Erlangen, Germany.

Ted Bosworth/Medscape Medical News

The report of high rates of activity and low relative risk of serious adverse events from the same series was published earlier this year in The New England Journal of Medicine when the median follow-up was 15 months. Almost all of the patients have now completed at least 1 year of follow-up and about a third have completed more than 2 years.
 

SLE Is Frequently Targeted in CAR T-Cell Studies

The three rheumatic diseases represented in this series of patients, all of whom had failed multiple previous immune suppressive treatments, were systemic lupus erythematosus (SLE), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). After the autologous T cells were harvested, they were expanded and transfected with the CD19 CAR. The proprietary investigational product, called MB-CART19.1 (Miltenyi Biotec), was administered in a single dose of one million cells per kg bodyweight.

The response rates have been, and continue to be, impressive. For the eight patients with SLE, all achieved the definition of remission in SLE criteria after one dose of treatment. Complete resolution of all major symptom types was achieved after 6 months of follow-up. So far, no patient has relapsed.

For the three patients with IIM, all reached the American College of Rheumatology–EULAR criteria for a major response. All creatine kinase levels had normalized by 3 months. In this group, there was one relapse, which occurred after 18 months of follow-up.

All four patients with SSc achieved a major response on the European Scleroderma Trials and Research (EUSTAR) group activity index. The median reduction from baseline in the EUSTAR score was 4.2 points, and this has been maintained in follow-up to date.
 

Remissions Have Persisted Off All Therapies

These remissions were achieved and maintained after a single dose of CAR T-cell therapy despite discontinuation of all immunosuppressive therapies. With the exception of the single relapse, all remissions have persisted through follow-up to date.

These responses were achieved with manageable side effects, according to Dr. Schett. The most serious adverse event was a grade 4 neutropenia that developed 4 months after receiving CAR T cells. It resolved with granulocyte colony-stimulating factor treatment. Cytokine release syndrome (CRS) has occurred in 10 patients, but it was grade 1 in eight patients and grade 2 in the others. There has been no neurotoxicity.

Almost all patients have experienced an infection during follow-up, but there has been no discernible pattern in relationship to the timing or types of infections. The most common have involved the upper respiratory tract and have been of mild severity, with cases disseminated similarly over early vs late follow-up. There was one case of pneumonia involving antibiotic treatment and a hospital stay, but it resolved.

Dr. Schett acknowledged that safety is a bigger concern in autoimmune diseases, which are often serious but rarely fatal, than in the hematologic malignancies for which CAR T cells were initially tested, but the low rates of serious adverse events in his and other early studies have supported the premise that the risks are not the same.

Asked specifically if CAR T cells can be considered a game changer in autoimmune rheumatic diseases, Dr. Schett was cautious. One reason is the CAR T cells are a complex therapy relative to biologic disease-modifying antirheumatic drugs. He thinks, therefore, that much more data are needed to confirm safety and efficacy. In addition, they are expensive, so it is not yet clear how they will be integrated with other options.

Yet, he thinks the evidence so far suggests a profound effect on the fundamental drivers of autoimmune disease. Their specific mechanism of benefit is still being evaluated, but he considers the clinical responses consistent with a “reset” hypothesis.

After a response, “we are seeing drug-free remissions in some patients as long as they have been followed,” Dr. Schett said. Based on the fact that disease control is being observed off all other therapies, “this only makes sense to me if there is some sort of immunologic reset.”
 

CAR T-Cell Studies in Autoimmune Diseases Are Proliferating

At last count, there were about 40 studies being performed with CAR T cells in various autoimmune diseases, most of which were rheumatologic disorders, according to Dr. Schett. He noted that funding is coming from multinational drug companies, small biotech startups, and investigator-initiated studies at academic centers.

At EULAR, beyond case studies and anecdotal reports, all of the clinical studies were still at the level of phase 1 or 1/2. Consistent with the data presented by Dr. Schett, the drugs have been nearly uniformly effective, with major responses persisting in patients off other therapies. Adverse events have been manageable.

Examples include a phase 1/2 multinational study with the investigational CAR T-cell therapy YTB323 (Novartis), which demonstrated acceptable safety and a strong signal of benefit in six patients with SLE. In this report, CRS was also common, but no case of CRS was more severe than grade 2. There was no neurotoxicity. Infections did occur but were of relatively mild grades and resolved with treatment.

For efficacy in the ongoing follow-up, SLE symptoms as measured with the SLE Disease Activity Index began to abate at about 14 days after the single-infusion treatment. Improvement on the Physician Global Assessment was also observed between 14 and 28 days. C3 and C4 complement levels started to rise at about 28 days. While the responses have correlated with the observed changes in biomarkers of immune function, they have endured through a median follow-up that now exceeds 6 months.
 

Complete B-Cell Depletion Is Followed by Full Recovery

“Pharmacokinetic and pharmacodynamic studies revealed peak expansion of CAR T cells approximately 13-21 days post infusion, which was accompanied by deep B-cell depletion followed by subsequent B-cell recovery,” reported Josefina Cortés-Hernández, MD, PhD, a senior lecturer at Vall d’Hebron Research Institute, Barcelona, Spain.

Dr. Schett had reported the same pattern of expansion followed by a rapid elimination of detectable CAR T cells despite the sustained clinical benefit.

Dr. Cortés-Hernández said that the signal of efficacy in the context of acceptable safety supports an expansion of clinical studies with this CAR T-cell product in SLE and perhaps other autoimmune disorders.

In another early-stage study, patients with SLE who had failed multiple prior lines of therapy have been enrolled in an ongoing study with a compound CAR (cCAR) T cell. This experimental proprietary product (iCAR Bio Therapeutics, Zhongshan, China) targets both the B-cell maturation antigen and CD19, according to Greg Deener, the chief executive officer of iCell Gene Therapeutics, New York City.

Ted Bosworth/Medscape Medical News

cCAR T-Cell Construct Targets Immune Reset

With this construct, the goal is to deplete long-lived plasma cells as well as B cells in order to achieve a more complete humoral reset. While preliminary data from the phase 1 trial were published earlier this year in Annals of the Rheumatic Diseases, Mr. Deener focused his presentation at EULAR 2024 on 12 patients with SLE and lupus nephritis, a severe form of SLE that threatens glomerular structures and can lead to end-stage liver disease.

B cells in the peripheral blood could not be detected within 10 days of the cCAR infusion, and the immunoglobulins IgM and IgA were undetectable by day 42.

However, after B-cell recovery by day 150, “flow cytometry and B-cell receptor sequencing confirmed full humoral reset was achieved,” Mr. Deener said.

The remission has been durable in 11 of the 12 patients after a mean follow-up of 458 days, Mr. Deener reported. He noted that an improvement in renal function has been observed in the majority of patients.

Like others, he reported that treatment has been relatively well tolerated. In this series of patients, there have been no cases of CRS more severe than grade 1.

Overall, the cCAR data in lupus nephritis support the hypothesis that CAR T cells are reprogramming the immune system, according to Mr. Deener.

Combined with a reasonable safety profile, the consistency of benefit from CAR T cells in autoimmune rheumatic diseases is good news, but all of the investigators who spoke at EULAR agreed that there are still many unanswered questions. Not least, it is unclear whether patients can be effectively and safely retreated when and if relapses occur. Even though Dr. Schett did report a response with retreatment following a relapse, he said that there is no conclusion to draw from a single patient.

Yet, the high rates of remissions in patients with disease refractory to other therapeutic options is highly encouraging, particularly with the manageable side effects now reported by multiple investigators using different CAR T-cell products.

“Roughly 100 patients with rheumatic diseases have been treated with CAR T-cells, and we have not seen a high-grade CRS or neurotoxicity,” he said.

Long-term efficacy is less clear. With the first clinical studies in autoimmune diseases initiated in 2021, few patients have been followed for more than 2 years. Even with the high rates of response that will certainly fuel efforts to rapidly bring these treatments forward, long-term data are now the missing piece.
 

Other Case Series Presented at EULAR

Several other abstracts reported on patients with SSc who were treated with CD19-targeting CAR T cells:

Three patients for whom autologous hematopoietic stem cell transplantation was contraindicated or unsuccessful were successfully and safely treated.

Six patients with diffuse and progressive disease achieved stable disease activity without additional immunosuppression for up to 1 year after treatment.

Dr. Schett reported no potential conflicts of interest, and the study he presented was not funded by industry. Dr. Cortés-Hernández reported a financial relationship with Novartis, which funded the study of the CAR T-cell therapy YTB323, as well as with GlaxoSmithKline, which was not involved in the study she presented.  Mr. Deener is an employee of iCell Gene Therapeutics, which provided funding for the trial he presented.

August 7, 2024 — Editor's note: This article was updated with additional disclosure information for Dr. Josefina Cortés-Hernández.

A version of this article appeared on Medscape.com.

VIENNA — From a dozen or so studies and sessions devoted to the role of chimeric antigen receptor (CAR) T cells in rheumatic diseases at the annual European Congress of Rheumatology, the message was uniformly positive, supporting growing evidence that drugs in this class are heading toward a paradigm shift in refractory rheumatic diseases.

Of the reports, an update from a 15-patient case series with at least 1 year of follow-up provides “the first long-term evidence of safety and efficacy in multiple rheumatic diseases,” according to Georg Schett, MD, PhD, director of rheumatology and immunology, University of Erlangen-Nürnberg, Erlangen, Germany.

Ted Bosworth/Medscape Medical News

The report of high rates of activity and low relative risk of serious adverse events from the same series was published earlier this year in The New England Journal of Medicine when the median follow-up was 15 months. Almost all of the patients have now completed at least 1 year of follow-up and about a third have completed more than 2 years.
 

SLE Is Frequently Targeted in CAR T-Cell Studies

The three rheumatic diseases represented in this series of patients, all of whom had failed multiple previous immune suppressive treatments, were systemic lupus erythematosus (SLE), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). After the autologous T cells were harvested, they were expanded and transfected with the CD19 CAR. The proprietary investigational product, called MB-CART19.1 (Miltenyi Biotec), was administered in a single dose of one million cells per kg bodyweight.

The response rates have been, and continue to be, impressive. For the eight patients with SLE, all achieved the definition of remission in SLE criteria after one dose of treatment. Complete resolution of all major symptom types was achieved after 6 months of follow-up. So far, no patient has relapsed.

For the three patients with IIM, all reached the American College of Rheumatology–EULAR criteria for a major response. All creatine kinase levels had normalized by 3 months. In this group, there was one relapse, which occurred after 18 months of follow-up.

All four patients with SSc achieved a major response on the European Scleroderma Trials and Research (EUSTAR) group activity index. The median reduction from baseline in the EUSTAR score was 4.2 points, and this has been maintained in follow-up to date.
 

Remissions Have Persisted Off All Therapies

These remissions were achieved and maintained after a single dose of CAR T-cell therapy despite discontinuation of all immunosuppressive therapies. With the exception of the single relapse, all remissions have persisted through follow-up to date.

These responses were achieved with manageable side effects, according to Dr. Schett. The most serious adverse event was a grade 4 neutropenia that developed 4 months after receiving CAR T cells. It resolved with granulocyte colony-stimulating factor treatment. Cytokine release syndrome (CRS) has occurred in 10 patients, but it was grade 1 in eight patients and grade 2 in the others. There has been no neurotoxicity.

Almost all patients have experienced an infection during follow-up, but there has been no discernible pattern in relationship to the timing or types of infections. The most common have involved the upper respiratory tract and have been of mild severity, with cases disseminated similarly over early vs late follow-up. There was one case of pneumonia involving antibiotic treatment and a hospital stay, but it resolved.

Dr. Schett acknowledged that safety is a bigger concern in autoimmune diseases, which are often serious but rarely fatal, than in the hematologic malignancies for which CAR T cells were initially tested, but the low rates of serious adverse events in his and other early studies have supported the premise that the risks are not the same.

Asked specifically if CAR T cells can be considered a game changer in autoimmune rheumatic diseases, Dr. Schett was cautious. One reason is the CAR T cells are a complex therapy relative to biologic disease-modifying antirheumatic drugs. He thinks, therefore, that much more data are needed to confirm safety and efficacy. In addition, they are expensive, so it is not yet clear how they will be integrated with other options.

Yet, he thinks the evidence so far suggests a profound effect on the fundamental drivers of autoimmune disease. Their specific mechanism of benefit is still being evaluated, but he considers the clinical responses consistent with a “reset” hypothesis.

After a response, “we are seeing drug-free remissions in some patients as long as they have been followed,” Dr. Schett said. Based on the fact that disease control is being observed off all other therapies, “this only makes sense to me if there is some sort of immunologic reset.”
 

CAR T-Cell Studies in Autoimmune Diseases Are Proliferating

At last count, there were about 40 studies being performed with CAR T cells in various autoimmune diseases, most of which were rheumatologic disorders, according to Dr. Schett. He noted that funding is coming from multinational drug companies, small biotech startups, and investigator-initiated studies at academic centers.

At EULAR, beyond case studies and anecdotal reports, all of the clinical studies were still at the level of phase 1 or 1/2. Consistent with the data presented by Dr. Schett, the drugs have been nearly uniformly effective, with major responses persisting in patients off other therapies. Adverse events have been manageable.

Examples include a phase 1/2 multinational study with the investigational CAR T-cell therapy YTB323 (Novartis), which demonstrated acceptable safety and a strong signal of benefit in six patients with SLE. In this report, CRS was also common, but no case of CRS was more severe than grade 2. There was no neurotoxicity. Infections did occur but were of relatively mild grades and resolved with treatment.

For efficacy in the ongoing follow-up, SLE symptoms as measured with the SLE Disease Activity Index began to abate at about 14 days after the single-infusion treatment. Improvement on the Physician Global Assessment was also observed between 14 and 28 days. C3 and C4 complement levels started to rise at about 28 days. While the responses have correlated with the observed changes in biomarkers of immune function, they have endured through a median follow-up that now exceeds 6 months.
 

Complete B-Cell Depletion Is Followed by Full Recovery

“Pharmacokinetic and pharmacodynamic studies revealed peak expansion of CAR T cells approximately 13-21 days post infusion, which was accompanied by deep B-cell depletion followed by subsequent B-cell recovery,” reported Josefina Cortés-Hernández, MD, PhD, a senior lecturer at Vall d’Hebron Research Institute, Barcelona, Spain.

Dr. Schett had reported the same pattern of expansion followed by a rapid elimination of detectable CAR T cells despite the sustained clinical benefit.

Dr. Cortés-Hernández said that the signal of efficacy in the context of acceptable safety supports an expansion of clinical studies with this CAR T-cell product in SLE and perhaps other autoimmune disorders.

In another early-stage study, patients with SLE who had failed multiple prior lines of therapy have been enrolled in an ongoing study with a compound CAR (cCAR) T cell. This experimental proprietary product (iCAR Bio Therapeutics, Zhongshan, China) targets both the B-cell maturation antigen and CD19, according to Greg Deener, the chief executive officer of iCell Gene Therapeutics, New York City.

Ted Bosworth/Medscape Medical News

cCAR T-Cell Construct Targets Immune Reset

With this construct, the goal is to deplete long-lived plasma cells as well as B cells in order to achieve a more complete humoral reset. While preliminary data from the phase 1 trial were published earlier this year in Annals of the Rheumatic Diseases, Mr. Deener focused his presentation at EULAR 2024 on 12 patients with SLE and lupus nephritis, a severe form of SLE that threatens glomerular structures and can lead to end-stage liver disease.

B cells in the peripheral blood could not be detected within 10 days of the cCAR infusion, and the immunoglobulins IgM and IgA were undetectable by day 42.

However, after B-cell recovery by day 150, “flow cytometry and B-cell receptor sequencing confirmed full humoral reset was achieved,” Mr. Deener said.

The remission has been durable in 11 of the 12 patients after a mean follow-up of 458 days, Mr. Deener reported. He noted that an improvement in renal function has been observed in the majority of patients.

Like others, he reported that treatment has been relatively well tolerated. In this series of patients, there have been no cases of CRS more severe than grade 1.

Overall, the cCAR data in lupus nephritis support the hypothesis that CAR T cells are reprogramming the immune system, according to Mr. Deener.

Combined with a reasonable safety profile, the consistency of benefit from CAR T cells in autoimmune rheumatic diseases is good news, but all of the investigators who spoke at EULAR agreed that there are still many unanswered questions. Not least, it is unclear whether patients can be effectively and safely retreated when and if relapses occur. Even though Dr. Schett did report a response with retreatment following a relapse, he said that there is no conclusion to draw from a single patient.

Yet, the high rates of remissions in patients with disease refractory to other therapeutic options is highly encouraging, particularly with the manageable side effects now reported by multiple investigators using different CAR T-cell products.

“Roughly 100 patients with rheumatic diseases have been treated with CAR T-cells, and we have not seen a high-grade CRS or neurotoxicity,” he said.

Long-term efficacy is less clear. With the first clinical studies in autoimmune diseases initiated in 2021, few patients have been followed for more than 2 years. Even with the high rates of response that will certainly fuel efforts to rapidly bring these treatments forward, long-term data are now the missing piece.
 

Other Case Series Presented at EULAR

Several other abstracts reported on patients with SSc who were treated with CD19-targeting CAR T cells:

Three patients for whom autologous hematopoietic stem cell transplantation was contraindicated or unsuccessful were successfully and safely treated.

Six patients with diffuse and progressive disease achieved stable disease activity without additional immunosuppression for up to 1 year after treatment.

Dr. Schett reported no potential conflicts of interest, and the study he presented was not funded by industry. Dr. Cortés-Hernández reported a financial relationship with Novartis, which funded the study of the CAR T-cell therapy YTB323, as well as with GlaxoSmithKline, which was not involved in the study she presented.  Mr. Deener is an employee of iCell Gene Therapeutics, which provided funding for the trial he presented.

August 7, 2024 — Editor's note: This article was updated with additional disclosure information for Dr. Josefina Cortés-Hernández.

A version of this article appeared on Medscape.com.

VIENNA — From a dozen or so studies and sessions devoted to the role of chimeric antigen receptor (CAR) T cells in rheumatic diseases at the annual European Congress of Rheumatology, the message was uniformly positive, supporting growing evidence that drugs in this class are heading toward a paradigm shift in refractory rheumatic diseases.

Of the reports, an update from a 15-patient case series with at least 1 year of follow-up provides “the first long-term evidence of safety and efficacy in multiple rheumatic diseases,” according to Georg Schett, MD, PhD, director of rheumatology and immunology, University of Erlangen-Nürnberg, Erlangen, Germany.

Ted Bosworth/Medscape Medical News

The report of high rates of activity and low relative risk of serious adverse events from the same series was published earlier this year in The New England Journal of Medicine when the median follow-up was 15 months. Almost all of the patients have now completed at least 1 year of follow-up and about a third have completed more than 2 years.
 

SLE Is Frequently Targeted in CAR T-Cell Studies

The three rheumatic diseases represented in this series of patients, all of whom had failed multiple previous immune suppressive treatments, were systemic lupus erythematosus (SLE), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). After the autologous T cells were harvested, they were expanded and transfected with the CD19 CAR. The proprietary investigational product, called MB-CART19.1 (Miltenyi Biotec), was administered in a single dose of one million cells per kg bodyweight.

The response rates have been, and continue to be, impressive. For the eight patients with SLE, all achieved the definition of remission in SLE criteria after one dose of treatment. Complete resolution of all major symptom types was achieved after 6 months of follow-up. So far, no patient has relapsed.

For the three patients with IIM, all reached the American College of Rheumatology–EULAR criteria for a major response. All creatine kinase levels had normalized by 3 months. In this group, there was one relapse, which occurred after 18 months of follow-up.

All four patients with SSc achieved a major response on the European Scleroderma Trials and Research (EUSTAR) group activity index. The median reduction from baseline in the EUSTAR score was 4.2 points, and this has been maintained in follow-up to date.
 

Remissions Have Persisted Off All Therapies

These remissions were achieved and maintained after a single dose of CAR T-cell therapy despite discontinuation of all immunosuppressive therapies. With the exception of the single relapse, all remissions have persisted through follow-up to date.

These responses were achieved with manageable side effects, according to Dr. Schett. The most serious adverse event was a grade 4 neutropenia that developed 4 months after receiving CAR T cells. It resolved with granulocyte colony-stimulating factor treatment. Cytokine release syndrome (CRS) has occurred in 10 patients, but it was grade 1 in eight patients and grade 2 in the others. There has been no neurotoxicity.

Almost all patients have experienced an infection during follow-up, but there has been no discernible pattern in relationship to the timing or types of infections. The most common have involved the upper respiratory tract and have been of mild severity, with cases disseminated similarly over early vs late follow-up. There was one case of pneumonia involving antibiotic treatment and a hospital stay, but it resolved.

Dr. Schett acknowledged that safety is a bigger concern in autoimmune diseases, which are often serious but rarely fatal, than in the hematologic malignancies for which CAR T cells were initially tested, but the low rates of serious adverse events in his and other early studies have supported the premise that the risks are not the same.

Asked specifically if CAR T cells can be considered a game changer in autoimmune rheumatic diseases, Dr. Schett was cautious. One reason is the CAR T cells are a complex therapy relative to biologic disease-modifying antirheumatic drugs. He thinks, therefore, that much more data are needed to confirm safety and efficacy. In addition, they are expensive, so it is not yet clear how they will be integrated with other options.

Yet, he thinks the evidence so far suggests a profound effect on the fundamental drivers of autoimmune disease. Their specific mechanism of benefit is still being evaluated, but he considers the clinical responses consistent with a “reset” hypothesis.

After a response, “we are seeing drug-free remissions in some patients as long as they have been followed,” Dr. Schett said. Based on the fact that disease control is being observed off all other therapies, “this only makes sense to me if there is some sort of immunologic reset.”
 

CAR T-Cell Studies in Autoimmune Diseases Are Proliferating

At last count, there were about 40 studies being performed with CAR T cells in various autoimmune diseases, most of which were rheumatologic disorders, according to Dr. Schett. He noted that funding is coming from multinational drug companies, small biotech startups, and investigator-initiated studies at academic centers.

At EULAR, beyond case studies and anecdotal reports, all of the clinical studies were still at the level of phase 1 or 1/2. Consistent with the data presented by Dr. Schett, the drugs have been nearly uniformly effective, with major responses persisting in patients off other therapies. Adverse events have been manageable.

Examples include a phase 1/2 multinational study with the investigational CAR T-cell therapy YTB323 (Novartis), which demonstrated acceptable safety and a strong signal of benefit in six patients with SLE. In this report, CRS was also common, but no case of CRS was more severe than grade 2. There was no neurotoxicity. Infections did occur but were of relatively mild grades and resolved with treatment.

For efficacy in the ongoing follow-up, SLE symptoms as measured with the SLE Disease Activity Index began to abate at about 14 days after the single-infusion treatment. Improvement on the Physician Global Assessment was also observed between 14 and 28 days. C3 and C4 complement levels started to rise at about 28 days. While the responses have correlated with the observed changes in biomarkers of immune function, they have endured through a median follow-up that now exceeds 6 months.
 

Complete B-Cell Depletion Is Followed by Full Recovery

“Pharmacokinetic and pharmacodynamic studies revealed peak expansion of CAR T cells approximately 13-21 days post infusion, which was accompanied by deep B-cell depletion followed by subsequent B-cell recovery,” reported Josefina Cortés-Hernández, MD, PhD, a senior lecturer at Vall d’Hebron Research Institute, Barcelona, Spain.

Dr. Schett had reported the same pattern of expansion followed by a rapid elimination of detectable CAR T cells despite the sustained clinical benefit.

Dr. Cortés-Hernández said that the signal of efficacy in the context of acceptable safety supports an expansion of clinical studies with this CAR T-cell product in SLE and perhaps other autoimmune disorders.

In another early-stage study, patients with SLE who had failed multiple prior lines of therapy have been enrolled in an ongoing study with a compound CAR (cCAR) T cell. This experimental proprietary product (iCAR Bio Therapeutics, Zhongshan, China) targets both the B-cell maturation antigen and CD19, according to Greg Deener, the chief executive officer of iCell Gene Therapeutics, New York City.

Ted Bosworth/Medscape Medical News

cCAR T-Cell Construct Targets Immune Reset

With this construct, the goal is to deplete long-lived plasma cells as well as B cells in order to achieve a more complete humoral reset. While preliminary data from the phase 1 trial were published earlier this year in Annals of the Rheumatic Diseases, Mr. Deener focused his presentation at EULAR 2024 on 12 patients with SLE and lupus nephritis, a severe form of SLE that threatens glomerular structures and can lead to end-stage liver disease.

B cells in the peripheral blood could not be detected within 10 days of the cCAR infusion, and the immunoglobulins IgM and IgA were undetectable by day 42.

However, after B-cell recovery by day 150, “flow cytometry and B-cell receptor sequencing confirmed full humoral reset was achieved,” Mr. Deener said.

The remission has been durable in 11 of the 12 patients after a mean follow-up of 458 days, Mr. Deener reported. He noted that an improvement in renal function has been observed in the majority of patients.

Like others, he reported that treatment has been relatively well tolerated. In this series of patients, there have been no cases of CRS more severe than grade 1.

Overall, the cCAR data in lupus nephritis support the hypothesis that CAR T cells are reprogramming the immune system, according to Mr. Deener.

Combined with a reasonable safety profile, the consistency of benefit from CAR T cells in autoimmune rheumatic diseases is good news, but all of the investigators who spoke at EULAR agreed that there are still many unanswered questions. Not least, it is unclear whether patients can be effectively and safely retreated when and if relapses occur. Even though Dr. Schett did report a response with retreatment following a relapse, he said that there is no conclusion to draw from a single patient.

Yet, the high rates of remissions in patients with disease refractory to other therapeutic options is highly encouraging, particularly with the manageable side effects now reported by multiple investigators using different CAR T-cell products.

“Roughly 100 patients with rheumatic diseases have been treated with CAR T-cells, and we have not seen a high-grade CRS or neurotoxicity,” he said.

Long-term efficacy is less clear. With the first clinical studies in autoimmune diseases initiated in 2021, few patients have been followed for more than 2 years. Even with the high rates of response that will certainly fuel efforts to rapidly bring these treatments forward, long-term data are now the missing piece.
 

Other Case Series Presented at EULAR

Several other abstracts reported on patients with SSc who were treated with CD19-targeting CAR T cells:

Three patients for whom autologous hematopoietic stem cell transplantation was contraindicated or unsuccessful were successfully and safely treated.

Six patients with diffuse and progressive disease achieved stable disease activity without additional immunosuppression for up to 1 year after treatment.

Dr. Schett reported no potential conflicts of interest, and the study he presented was not funded by industry. Dr. Cortés-Hernández reported a financial relationship with Novartis, which funded the study of the CAR T-cell therapy YTB323, as well as with GlaxoSmithKline, which was not involved in the study she presented.  Mr. Deener is an employee of iCell Gene Therapeutics, which provided funding for the trial he presented.

August 7, 2024 — Editor's note: This article was updated with additional disclosure information for Dr. Josefina Cortés-Hernández.

A version of this article appeared on Medscape.com.

TOPLINE:

Long-term, supervised exercise therapy significantly improves the functional ability and quality of life in patients with axial spondyloarthritis (axSpA) and severe functional limitations.
 

METHODOLOGY:

• This 52-week study evaluated the effectiveness of personalized exercise therapy in adults with axSpA and severe functional limitations.
• Overall, 214 participants were randomly allocated to either a personalized exercise therapy regimen or usual care for 52 weeks.
• The supervised exercise therapy regimen consisted of various exercises, patient education, goal setting, and physical activity promotion for up to 64 sessions.
• The primary endpoint was a change in the highest-ranked Patient-Specific Complaints Numeric Rating Scale (PSC1) score at 52 weeks, and secondary endpoints included measures of physical functioning and quality of life.

TAKEAWAY:

• At 52 weeks, the exercise group showed a greater improvement in the primary outcome measure (PSC1) than the usual-care group, with a mean difference of −1.8 (95% CI, −2.4 to −1.2).
• Exercise therapy led to significant improvements in functional disability and physical quality of life.
• No serious adverse events related to the intervention were reported, highlighting the safety of exercise therapy.

IN PRACTICE:

“If guided by a trained physical therapist applying a personalized approach, people with severe functional limitations due to an unfavorable course or comorbidities can be just as responsive to training as people with axSpA without severe limitations,” the authors wrote.
 

SOURCE:

The study was led by Maria A.T. van Wissen, Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands, and published online in Rheumatology.
 

LIMITATIONS:

The study’s reliance on self-reported data for axSpA treatment-related medication may have compromised accuracy. Additionally, the lack of information on medication changes during the study period could affect result interpretation.
 

DISCLOSURES:

The study was supported by grants from the Netherlands Organization for Health Research and Development; Ministry of Health, Welfare and Sport; Royal Dutch Society for Physical Therapy; and Dutch Arthritis Society. The authors declared no conflicts of interest.

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:

Long-term, supervised exercise therapy significantly improves the functional ability and quality of life in patients with axial spondyloarthritis (axSpA) and severe functional limitations.
 

METHODOLOGY:

• This 52-week study evaluated the effectiveness of personalized exercise therapy in adults with axSpA and severe functional limitations.
• Overall, 214 participants were randomly allocated to either a personalized exercise therapy regimen or usual care for 52 weeks.
• The supervised exercise therapy regimen consisted of various exercises, patient education, goal setting, and physical activity promotion for up to 64 sessions.
• The primary endpoint was a change in the highest-ranked Patient-Specific Complaints Numeric Rating Scale (PSC1) score at 52 weeks, and secondary endpoints included measures of physical functioning and quality of life.

TAKEAWAY:

• At 52 weeks, the exercise group showed a greater improvement in the primary outcome measure (PSC1) than the usual-care group, with a mean difference of −1.8 (95% CI, −2.4 to −1.2).
• Exercise therapy led to significant improvements in functional disability and physical quality of life.
• No serious adverse events related to the intervention were reported, highlighting the safety of exercise therapy.

IN PRACTICE:

“If guided by a trained physical therapist applying a personalized approach, people with severe functional limitations due to an unfavorable course or comorbidities can be just as responsive to training as people with axSpA without severe limitations,” the authors wrote.
 

SOURCE:

The study was led by Maria A.T. van Wissen, Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands, and published online in Rheumatology.
 

LIMITATIONS:

The study’s reliance on self-reported data for axSpA treatment-related medication may have compromised accuracy. Additionally, the lack of information on medication changes during the study period could affect result interpretation.
 

DISCLOSURES:

The study was supported by grants from the Netherlands Organization for Health Research and Development; Ministry of Health, Welfare and Sport; Royal Dutch Society for Physical Therapy; and Dutch Arthritis Society. The authors declared no conflicts of interest.

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:

Long-term, supervised exercise therapy significantly improves the functional ability and quality of life in patients with axial spondyloarthritis (axSpA) and severe functional limitations.
 

METHODOLOGY:

• This 52-week study evaluated the effectiveness of personalized exercise therapy in adults with axSpA and severe functional limitations.
• Overall, 214 participants were randomly allocated to either a personalized exercise therapy regimen or usual care for 52 weeks.
• The supervised exercise therapy regimen consisted of various exercises, patient education, goal setting, and physical activity promotion for up to 64 sessions.
• The primary endpoint was a change in the highest-ranked Patient-Specific Complaints Numeric Rating Scale (PSC1) score at 52 weeks, and secondary endpoints included measures of physical functioning and quality of life.

TAKEAWAY:

• At 52 weeks, the exercise group showed a greater improvement in the primary outcome measure (PSC1) than the usual-care group, with a mean difference of −1.8 (95% CI, −2.4 to −1.2).
• Exercise therapy led to significant improvements in functional disability and physical quality of life.
• No serious adverse events related to the intervention were reported, highlighting the safety of exercise therapy.

IN PRACTICE:

“If guided by a trained physical therapist applying a personalized approach, people with severe functional limitations due to an unfavorable course or comorbidities can be just as responsive to training as people with axSpA without severe limitations,” the authors wrote.
 

SOURCE:

The study was led by Maria A.T. van Wissen, Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands, and published online in Rheumatology.
 

LIMITATIONS:

The study’s reliance on self-reported data for axSpA treatment-related medication may have compromised accuracy. Additionally, the lack of information on medication changes during the study period could affect result interpretation.
 

DISCLOSURES:

The study was supported by grants from the Netherlands Organization for Health Research and Development; Ministry of Health, Welfare and Sport; Royal Dutch Society for Physical Therapy; and Dutch Arthritis Society. The authors declared no conflicts of interest.

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.

Mount Sinai Health System in New York City is forcing part-time physicians to sign employment contracts that violate their labor rights, according to a June 2024 complaint by the National Labor Relations Board (NLRB). 

The complaint stems from no-poaching and confidentiality clauses in the agreements required as a condition of employment, NLRB officials alleged.

The contracts state that, for 1 year following termination, part-time physicians may not recruit, solicit, or induce to terminate the employment of any hospital system employee or independent contractor, according to a copy of the terms included in NLRB’s June 18 complaint. 

By requiring the agreements, NLRB officials claimed, Mount Sinai is “interfering with, restraining, and coercing employees” in violation of the National Labor Relations Act. The health system’s “unfair labor practices” affects commerce as outlined under the law, according to the NLRB. The Act bans employers from burdening or obstructing commerce or the free flow of commerce.

Mount Sinai did not respond to requests for comment.

The NLRB’s complaint follows a landmark decision by the Federal Trade Commission (FTC) to ban noncompete agreements nationwide. In April 2024, the FTC voted to prohibit noncompetes indefinitely in an effort to protect workers.

“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8500 new startups that would be created a year once noncompetes are banned,” FTC Chair Lina M. Khan said in a statement. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”

Business groups and agencies have since sued to challenge against the ban, including the Chamber of Commerce. The Chamber and other business groups argue that noncompete agreements are important for companies to protect trade secrets, shield recruiting investments, and hide confidential information. The lawsuits are ongoing. 
 

A Physician Blows the Whistle

An anonymous physician first alerted the NLRB to the contract language in November 2023. The doctor was required the sign the hospital system’s agreement for part-time physicians. The complaint does not say if the employee is still employed by the hospital system. 

To remedy the unfair labor practices alleged, the NLRB seeks an order requiring the health system to rescind the contract language, stop any actions against current or former employees to enforce the provisions, and make whole any employees who suffered financial losses related to the contract terms. 

The allegation against Mount Sinai is among a rising number of grievances filed with the NLRB that claim unfair labor practices. During the first 6 months of fiscal year 2024, unfair labor practice charges filed across the NLRB’s field offices increased 7% — from 9612 in 2023 to 10,278 in 2024, according to a news release. 

NLRB, meanwhile has been cracking down on anticompetitive labor practices and confidentiality provisions that prevent employees from speaking out. 

In a February 2023 decision for instance, NLRB ruled that an employer violates the National Labor Relations Act by offering severance agreements to workers that include restrictive confidentiality and nondisparagement terms. In 2022, the NLRB and the Federal Trade Commission forged a partnership to more widely combat unfair, anticompetitive, and deceptive business practices. 

“Noncompete provisions reasonably tend to chill employees in the exercise of Section 7 rights when the provisions could reasonably be construed by employees to deny them the ability to quit or change jobs by cutting off their access to other employment opportunities that they are qualified for,” NLRB General Counsel Jennifer Abruzzo said in a 2023 release. 

Ms. Abruzzo stressed in a memo that NLR Act is committed to an interagency approach to restrictions on the exercise of employee rights, “including limits to workers’ job mobility, information sharing, and referrals to other agencies.” 

Mount Sinai Health System must respond to the NLRB’s complaint by July 16, and an administrative law judge is scheduled to hear the case on September 24.

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

Mount Sinai Health System in New York City is forcing part-time physicians to sign employment contracts that violate their labor rights, according to a June 2024 complaint by the National Labor Relations Board (NLRB). 

The complaint stems from no-poaching and confidentiality clauses in the agreements required as a condition of employment, NLRB officials alleged.

The contracts state that, for 1 year following termination, part-time physicians may not recruit, solicit, or induce to terminate the employment of any hospital system employee or independent contractor, according to a copy of the terms included in NLRB’s June 18 complaint. 

By requiring the agreements, NLRB officials claimed, Mount Sinai is “interfering with, restraining, and coercing employees” in violation of the National Labor Relations Act. The health system’s “unfair labor practices” affects commerce as outlined under the law, according to the NLRB. The Act bans employers from burdening or obstructing commerce or the free flow of commerce.

Mount Sinai did not respond to requests for comment.

The NLRB’s complaint follows a landmark decision by the Federal Trade Commission (FTC) to ban noncompete agreements nationwide. In April 2024, the FTC voted to prohibit noncompetes indefinitely in an effort to protect workers.

“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8500 new startups that would be created a year once noncompetes are banned,” FTC Chair Lina M. Khan said in a statement. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”

Business groups and agencies have since sued to challenge against the ban, including the Chamber of Commerce. The Chamber and other business groups argue that noncompete agreements are important for companies to protect trade secrets, shield recruiting investments, and hide confidential information. The lawsuits are ongoing. 
 

A Physician Blows the Whistle

An anonymous physician first alerted the NLRB to the contract language in November 2023. The doctor was required the sign the hospital system’s agreement for part-time physicians. The complaint does not say if the employee is still employed by the hospital system. 

To remedy the unfair labor practices alleged, the NLRB seeks an order requiring the health system to rescind the contract language, stop any actions against current or former employees to enforce the provisions, and make whole any employees who suffered financial losses related to the contract terms. 

The allegation against Mount Sinai is among a rising number of grievances filed with the NLRB that claim unfair labor practices. During the first 6 months of fiscal year 2024, unfair labor practice charges filed across the NLRB’s field offices increased 7% — from 9612 in 2023 to 10,278 in 2024, according to a news release. 

NLRB, meanwhile has been cracking down on anticompetitive labor practices and confidentiality provisions that prevent employees from speaking out. 

In a February 2023 decision for instance, NLRB ruled that an employer violates the National Labor Relations Act by offering severance agreements to workers that include restrictive confidentiality and nondisparagement terms. In 2022, the NLRB and the Federal Trade Commission forged a partnership to more widely combat unfair, anticompetitive, and deceptive business practices. 

“Noncompete provisions reasonably tend to chill employees in the exercise of Section 7 rights when the provisions could reasonably be construed by employees to deny them the ability to quit or change jobs by cutting off their access to other employment opportunities that they are qualified for,” NLRB General Counsel Jennifer Abruzzo said in a 2023 release. 

Ms. Abruzzo stressed in a memo that NLR Act is committed to an interagency approach to restrictions on the exercise of employee rights, “including limits to workers’ job mobility, information sharing, and referrals to other agencies.” 

Mount Sinai Health System must respond to the NLRB’s complaint by July 16, and an administrative law judge is scheduled to hear the case on September 24.

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

Mount Sinai Health System in New York City is forcing part-time physicians to sign employment contracts that violate their labor rights, according to a June 2024 complaint by the National Labor Relations Board (NLRB). 

The complaint stems from no-poaching and confidentiality clauses in the agreements required as a condition of employment, NLRB officials alleged.

The contracts state that, for 1 year following termination, part-time physicians may not recruit, solicit, or induce to terminate the employment of any hospital system employee or independent contractor, according to a copy of the terms included in NLRB’s June 18 complaint. 

By requiring the agreements, NLRB officials claimed, Mount Sinai is “interfering with, restraining, and coercing employees” in violation of the National Labor Relations Act. The health system’s “unfair labor practices” affects commerce as outlined under the law, according to the NLRB. The Act bans employers from burdening or obstructing commerce or the free flow of commerce.

Mount Sinai did not respond to requests for comment.

The NLRB’s complaint follows a landmark decision by the Federal Trade Commission (FTC) to ban noncompete agreements nationwide. In April 2024, the FTC voted to prohibit noncompetes indefinitely in an effort to protect workers.

“Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8500 new startups that would be created a year once noncompetes are banned,” FTC Chair Lina M. Khan said in a statement. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.”

Business groups and agencies have since sued to challenge against the ban, including the Chamber of Commerce. The Chamber and other business groups argue that noncompete agreements are important for companies to protect trade secrets, shield recruiting investments, and hide confidential information. The lawsuits are ongoing. 
 

A Physician Blows the Whistle

An anonymous physician first alerted the NLRB to the contract language in November 2023. The doctor was required the sign the hospital system’s agreement for part-time physicians. The complaint does not say if the employee is still employed by the hospital system. 

To remedy the unfair labor practices alleged, the NLRB seeks an order requiring the health system to rescind the contract language, stop any actions against current or former employees to enforce the provisions, and make whole any employees who suffered financial losses related to the contract terms. 

The allegation against Mount Sinai is among a rising number of grievances filed with the NLRB that claim unfair labor practices. During the first 6 months of fiscal year 2024, unfair labor practice charges filed across the NLRB’s field offices increased 7% — from 9612 in 2023 to 10,278 in 2024, according to a news release. 

NLRB, meanwhile has been cracking down on anticompetitive labor practices and confidentiality provisions that prevent employees from speaking out. 

In a February 2023 decision for instance, NLRB ruled that an employer violates the National Labor Relations Act by offering severance agreements to workers that include restrictive confidentiality and nondisparagement terms. In 2022, the NLRB and the Federal Trade Commission forged a partnership to more widely combat unfair, anticompetitive, and deceptive business practices. 

“Noncompete provisions reasonably tend to chill employees in the exercise of Section 7 rights when the provisions could reasonably be construed by employees to deny them the ability to quit or change jobs by cutting off their access to other employment opportunities that they are qualified for,” NLRB General Counsel Jennifer Abruzzo said in a 2023 release. 

Ms. Abruzzo stressed in a memo that NLR Act is committed to an interagency approach to restrictions on the exercise of employee rights, “including limits to workers’ job mobility, information sharing, and referrals to other agencies.” 

Mount Sinai Health System must respond to the NLRB’s complaint by July 16, and an administrative law judge is scheduled to hear the case on September 24.

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

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”