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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
On the Murder of UnitedHealthcare’s CEO
On December 4, UnitedHealthcare CEO Brian Thompson was assassinated in New York City outside of a hotel. As of the time of this writing, the shooter is still at large.
I suppose I could write about how this shows that Americans are fed up with the way modern commercial healthcare companies operate. Who gets care and who doesn’t.
I could write about how industry trends of “Delay, Deny, Defend” lead to the suffering of millions of people who need healthcare that they thought they were paying for.
I could write about the callousness of the way people online are celebrating the cold-blooded murder of a married man with two children.
I might write about how insurance companies intentionally, and routinely, drag out (or deny) reimbursements for physicians (including small solo practice ones, like myself) who are legitimately caring for their patients.
I suppose I could write something about how gun violence is so pervasive in our society that it scarcely merits a second glance at the news story. If the headline just said, “Unknown Assailant Kills Man Outside Hotel,” would you have even read beyond that?
I could write about how the lack of regulations, and accelerating attempts to scrap them, can lead to insider trading.
I could write about how having insurance companies and medical facilities more beholden to shareholders than to patients is a serious conflict of interest.
I could try to make points about how the widespread availability of firearms (in this case one with a built-in silencer) in America means that anyone with a vendetta, or serious mental illness, or just a short temper, can get one — and use it.
I could talk about how “greed is good” in healthcare settings rewards a few and hurts many — no matter how much the PR spinners try to make it sound like it’s a great win-win situation all-around.
I could argue that the jubilant “good riddance” and “eat the rich” responses of many — both medical and nonmedical people — to the killing shows that, as a society, we’re losing the qualities that make us human.
I could also argue that putting financial gain for executive bonuses and stockholder dividends ahead of the health and well-being of others shows that, as a society, we’re losing the qualities that make us human.
I could make a point that , provided the target is someone they have a difference of opinion with. Which is, honestly, pretty damn scary.
I could talk about how policies of arbitrarily changing the rules about anesthesia coverage, or letting a computer decide how long a hospital stay should be, or to deny rehabilitation care, are unethical, unjust, and just plain wrong.
I could write about a lot of things based on what happened outside that New York Hilton Midtown in early December.
But as I stare at my screen, I’m well aware that no matter what I write it won’t change any opinions, solve anything, or even lead to people trying to find a solution.
Because that’s just the world we live in.
Block has a solo neurology practice in Scottsdale, Arizona.
On December 4, UnitedHealthcare CEO Brian Thompson was assassinated in New York City outside of a hotel. As of the time of this writing, the shooter is still at large.
I suppose I could write about how this shows that Americans are fed up with the way modern commercial healthcare companies operate. Who gets care and who doesn’t.
I could write about how industry trends of “Delay, Deny, Defend” lead to the suffering of millions of people who need healthcare that they thought they were paying for.
I could write about the callousness of the way people online are celebrating the cold-blooded murder of a married man with two children.
I might write about how insurance companies intentionally, and routinely, drag out (or deny) reimbursements for physicians (including small solo practice ones, like myself) who are legitimately caring for their patients.
I suppose I could write something about how gun violence is so pervasive in our society that it scarcely merits a second glance at the news story. If the headline just said, “Unknown Assailant Kills Man Outside Hotel,” would you have even read beyond that?
I could write about how the lack of regulations, and accelerating attempts to scrap them, can lead to insider trading.
I could write about how having insurance companies and medical facilities more beholden to shareholders than to patients is a serious conflict of interest.
I could try to make points about how the widespread availability of firearms (in this case one with a built-in silencer) in America means that anyone with a vendetta, or serious mental illness, or just a short temper, can get one — and use it.
I could talk about how “greed is good” in healthcare settings rewards a few and hurts many — no matter how much the PR spinners try to make it sound like it’s a great win-win situation all-around.
I could argue that the jubilant “good riddance” and “eat the rich” responses of many — both medical and nonmedical people — to the killing shows that, as a society, we’re losing the qualities that make us human.
I could also argue that putting financial gain for executive bonuses and stockholder dividends ahead of the health and well-being of others shows that, as a society, we’re losing the qualities that make us human.
I could make a point that , provided the target is someone they have a difference of opinion with. Which is, honestly, pretty damn scary.
I could talk about how policies of arbitrarily changing the rules about anesthesia coverage, or letting a computer decide how long a hospital stay should be, or to deny rehabilitation care, are unethical, unjust, and just plain wrong.
I could write about a lot of things based on what happened outside that New York Hilton Midtown in early December.
But as I stare at my screen, I’m well aware that no matter what I write it won’t change any opinions, solve anything, or even lead to people trying to find a solution.
Because that’s just the world we live in.
Block has a solo neurology practice in Scottsdale, Arizona.
On December 4, UnitedHealthcare CEO Brian Thompson was assassinated in New York City outside of a hotel. As of the time of this writing, the shooter is still at large.
I suppose I could write about how this shows that Americans are fed up with the way modern commercial healthcare companies operate. Who gets care and who doesn’t.
I could write about how industry trends of “Delay, Deny, Defend” lead to the suffering of millions of people who need healthcare that they thought they were paying for.
I could write about the callousness of the way people online are celebrating the cold-blooded murder of a married man with two children.
I might write about how insurance companies intentionally, and routinely, drag out (or deny) reimbursements for physicians (including small solo practice ones, like myself) who are legitimately caring for their patients.
I suppose I could write something about how gun violence is so pervasive in our society that it scarcely merits a second glance at the news story. If the headline just said, “Unknown Assailant Kills Man Outside Hotel,” would you have even read beyond that?
I could write about how the lack of regulations, and accelerating attempts to scrap them, can lead to insider trading.
I could write about how having insurance companies and medical facilities more beholden to shareholders than to patients is a serious conflict of interest.
I could try to make points about how the widespread availability of firearms (in this case one with a built-in silencer) in America means that anyone with a vendetta, or serious mental illness, or just a short temper, can get one — and use it.
I could talk about how “greed is good” in healthcare settings rewards a few and hurts many — no matter how much the PR spinners try to make it sound like it’s a great win-win situation all-around.
I could argue that the jubilant “good riddance” and “eat the rich” responses of many — both medical and nonmedical people — to the killing shows that, as a society, we’re losing the qualities that make us human.
I could also argue that putting financial gain for executive bonuses and stockholder dividends ahead of the health and well-being of others shows that, as a society, we’re losing the qualities that make us human.
I could make a point that , provided the target is someone they have a difference of opinion with. Which is, honestly, pretty damn scary.
I could talk about how policies of arbitrarily changing the rules about anesthesia coverage, or letting a computer decide how long a hospital stay should be, or to deny rehabilitation care, are unethical, unjust, and just plain wrong.
I could write about a lot of things based on what happened outside that New York Hilton Midtown in early December.
But as I stare at my screen, I’m well aware that no matter what I write it won’t change any opinions, solve anything, or even lead to people trying to find a solution.
Because that’s just the world we live in.
Block has a solo neurology practice in Scottsdale, Arizona.
Rheumatology Match: Less than Half of Pediatric Positions Filled, Worsening Existing Trend
Over half of pediatric rheumatology fellowship positions went unfilled in 2024, according to the National Resident Matching Program (NRMP). Comparatively, nearly all adult rheumatology positions were filled.
Across all 39 subspecialties in internal medicine and pediatrics, there was an 86% fill rate. In pediatric subspecialties, the fill rate was 78%. There were more than 10,200 applicants in this year’s medicine and pediatric specialties match — a 9% increase from 2023 — and 81% matched to a position.
The NRMP reported that adult rheumatology filled 129 (97.7%) of 132 programs, with 284 (99%) out of 287 positions filled. In 2024, there were five new programs and 11 more fellowship positions available compared with the previous year.
In pediatric rheumatology, 16 (44%) of 36 programs were filled, with 27 (49%) of 55 positions filled. This is a notable decrease from 2023, where pediatric rheumatology filled 21 of 38 programs (55%) and 32 (62%) of 52 positions.
This year, 27 of 30 applicants preferring pediatric rheumatology matched to a program, while in 2023 all 32 applicants that preferred pediatric rheumatology matched.
“It’s a little disappointing that our overall number of applicants have not gone up,” Jay Mehta, MD, the program director of the Children’s Hospital of Philadelphia’s pediatric rheumatology fellowship said in an interview with Medscape Medical News. “It’s an especially exciting time in pediatric rheumatology, with really fantastic breakthroughs in terms of treatments and diagnostics. Unfortunately, that excitement hasn’t necessarily translated into more interest in our field.”
Mehta noted that the number of applicants to pediatric rheumatology fellowships have remained relatively consistent. Since 2019, the number of applicants has ranged from 28 to 33.
“Given the low number of overall positions/programs it is hard to read too much into year-to-year differences,” added Kristen Hayward, MD, a pediatric rheumatologist at Seattle Children’s in Washington. “While this total number of applicants per year is steady, this number is insufficient to build an adequate workforce for our current needs, much less for the future.”
This year, matched applicants to pediatric rheumatology included 13 MD graduates, eight DO graduates, five foreign applicants, and one US citizen international medical graduate.
In adult rheumatology, matched applicants included 108 MD graduates, 97 foreign applicants, 41 DO graduates, and 38 US citizen international medical graduates. A total of 365 applicants preferred the specialty, and 76% matched to rheumatology. Seven applicants matched to another specialty, and the remaining 79 did not match to any program.
Rheumatology was one of several specialties offering at least 150 positions with a fill rate of over 98%. The other specialties included allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, endocrinology, gastroenterology, and hematology and oncology.
While some pediatric subspecialties like critical care medicine and cardiology had fill rates over 90%, many “cognitive subspecialties” beyond pediatric rheumatology also struggled to fill spots, Hayward noted. Only 37% of pediatric nephrology positions and 48% of pediatric infectious disease positions were filled this year, in addition to a decline in filled pediatric-residency positions overall, she added.
Mehta had no relevant disclosures. Hayward previously owned stock/stock options for AbbVie/Abbott, Cigna/Express Scripts, Merck, and Teva and has received an educational grant from Pfizer.
A version of this article first appeared on Medscape.com.
Over half of pediatric rheumatology fellowship positions went unfilled in 2024, according to the National Resident Matching Program (NRMP). Comparatively, nearly all adult rheumatology positions were filled.
Across all 39 subspecialties in internal medicine and pediatrics, there was an 86% fill rate. In pediatric subspecialties, the fill rate was 78%. There were more than 10,200 applicants in this year’s medicine and pediatric specialties match — a 9% increase from 2023 — and 81% matched to a position.
The NRMP reported that adult rheumatology filled 129 (97.7%) of 132 programs, with 284 (99%) out of 287 positions filled. In 2024, there were five new programs and 11 more fellowship positions available compared with the previous year.
In pediatric rheumatology, 16 (44%) of 36 programs were filled, with 27 (49%) of 55 positions filled. This is a notable decrease from 2023, where pediatric rheumatology filled 21 of 38 programs (55%) and 32 (62%) of 52 positions.
This year, 27 of 30 applicants preferring pediatric rheumatology matched to a program, while in 2023 all 32 applicants that preferred pediatric rheumatology matched.
“It’s a little disappointing that our overall number of applicants have not gone up,” Jay Mehta, MD, the program director of the Children’s Hospital of Philadelphia’s pediatric rheumatology fellowship said in an interview with Medscape Medical News. “It’s an especially exciting time in pediatric rheumatology, with really fantastic breakthroughs in terms of treatments and diagnostics. Unfortunately, that excitement hasn’t necessarily translated into more interest in our field.”
Mehta noted that the number of applicants to pediatric rheumatology fellowships have remained relatively consistent. Since 2019, the number of applicants has ranged from 28 to 33.
“Given the low number of overall positions/programs it is hard to read too much into year-to-year differences,” added Kristen Hayward, MD, a pediatric rheumatologist at Seattle Children’s in Washington. “While this total number of applicants per year is steady, this number is insufficient to build an adequate workforce for our current needs, much less for the future.”
This year, matched applicants to pediatric rheumatology included 13 MD graduates, eight DO graduates, five foreign applicants, and one US citizen international medical graduate.
In adult rheumatology, matched applicants included 108 MD graduates, 97 foreign applicants, 41 DO graduates, and 38 US citizen international medical graduates. A total of 365 applicants preferred the specialty, and 76% matched to rheumatology. Seven applicants matched to another specialty, and the remaining 79 did not match to any program.
Rheumatology was one of several specialties offering at least 150 positions with a fill rate of over 98%. The other specialties included allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, endocrinology, gastroenterology, and hematology and oncology.
While some pediatric subspecialties like critical care medicine and cardiology had fill rates over 90%, many “cognitive subspecialties” beyond pediatric rheumatology also struggled to fill spots, Hayward noted. Only 37% of pediatric nephrology positions and 48% of pediatric infectious disease positions were filled this year, in addition to a decline in filled pediatric-residency positions overall, she added.
Mehta had no relevant disclosures. Hayward previously owned stock/stock options for AbbVie/Abbott, Cigna/Express Scripts, Merck, and Teva and has received an educational grant from Pfizer.
A version of this article first appeared on Medscape.com.
Over half of pediatric rheumatology fellowship positions went unfilled in 2024, according to the National Resident Matching Program (NRMP). Comparatively, nearly all adult rheumatology positions were filled.
Across all 39 subspecialties in internal medicine and pediatrics, there was an 86% fill rate. In pediatric subspecialties, the fill rate was 78%. There were more than 10,200 applicants in this year’s medicine and pediatric specialties match — a 9% increase from 2023 — and 81% matched to a position.
The NRMP reported that adult rheumatology filled 129 (97.7%) of 132 programs, with 284 (99%) out of 287 positions filled. In 2024, there were five new programs and 11 more fellowship positions available compared with the previous year.
In pediatric rheumatology, 16 (44%) of 36 programs were filled, with 27 (49%) of 55 positions filled. This is a notable decrease from 2023, where pediatric rheumatology filled 21 of 38 programs (55%) and 32 (62%) of 52 positions.
This year, 27 of 30 applicants preferring pediatric rheumatology matched to a program, while in 2023 all 32 applicants that preferred pediatric rheumatology matched.
“It’s a little disappointing that our overall number of applicants have not gone up,” Jay Mehta, MD, the program director of the Children’s Hospital of Philadelphia’s pediatric rheumatology fellowship said in an interview with Medscape Medical News. “It’s an especially exciting time in pediatric rheumatology, with really fantastic breakthroughs in terms of treatments and diagnostics. Unfortunately, that excitement hasn’t necessarily translated into more interest in our field.”
Mehta noted that the number of applicants to pediatric rheumatology fellowships have remained relatively consistent. Since 2019, the number of applicants has ranged from 28 to 33.
“Given the low number of overall positions/programs it is hard to read too much into year-to-year differences,” added Kristen Hayward, MD, a pediatric rheumatologist at Seattle Children’s in Washington. “While this total number of applicants per year is steady, this number is insufficient to build an adequate workforce for our current needs, much less for the future.”
This year, matched applicants to pediatric rheumatology included 13 MD graduates, eight DO graduates, five foreign applicants, and one US citizen international medical graduate.
In adult rheumatology, matched applicants included 108 MD graduates, 97 foreign applicants, 41 DO graduates, and 38 US citizen international medical graduates. A total of 365 applicants preferred the specialty, and 76% matched to rheumatology. Seven applicants matched to another specialty, and the remaining 79 did not match to any program.
Rheumatology was one of several specialties offering at least 150 positions with a fill rate of over 98%. The other specialties included allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, endocrinology, gastroenterology, and hematology and oncology.
While some pediatric subspecialties like critical care medicine and cardiology had fill rates over 90%, many “cognitive subspecialties” beyond pediatric rheumatology also struggled to fill spots, Hayward noted. Only 37% of pediatric nephrology positions and 48% of pediatric infectious disease positions were filled this year, in addition to a decline in filled pediatric-residency positions overall, she added.
Mehta had no relevant disclosures. Hayward previously owned stock/stock options for AbbVie/Abbott, Cigna/Express Scripts, Merck, and Teva and has received an educational grant from Pfizer.
A version of this article first appeared on Medscape.com.
Triple Therapy Now Advised for Lupus Nephritis in Updated Guideline
WASHINGTON — A new guideline for management of lupus nephritis (LN) was unveiled at the annual meeting of the American College of Rheumatology (ACR), updating the 2012 LN guideline to recommend a more aggressive first-line approach to treating the disease.
“The biggest differences are that we are recommending what we’re calling triple therapy, where we incorporate the glucocorticoid therapy with baseline conventional immunosuppressants, usually mycophenolate with cyclophosphamide, and the addition of one of the newer agents more recently approved by the FDA [Food and Drug Administration] — belimumab, voclosporin, or another CNI [calcineurin inhibitor],” said Lisa Sammaritano, MD, director of the Rheumatology Reproductive Health Program of the Barbara Volcker Center for Women and Rheumatic Diseases at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medical College, both in New York City.
“This is a bit of a change from not only our previous guideline but some of the other guidelines out there, and it is based on the fact that we have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients than starting with only two agents and waiting to see if they respond before escalating therapy,” she said. Other key updates include recommending use of pulse glucocorticoid therapy with a lower dose and more rapid steroid taper and treating patients with the recommended therapy for 3-5 years.
The guiding principles of the guideline are not only to preserve kidney function and minimize morbidity and mortality but also to ensure collaborative care with nephrology, to utilize shared decision-making that includes patients’ values and preferences, to reduce healthcare disparities, and to consider pediatric and geriatric populations. The guidelines are based on a quantitative synthesis of 105 studies that yielded 7 strong recommendations, 21 conditional recommendations, and 13 good practice statements — those commonly accepted as beneficial or practical advice even if there is little direct evidence to support them. The voting panel of 19 members included not only 3 nephrologists and 2 pediatric rheumatologists but also 2 patient representatives with LN.
The recommendations are just that, “a recommendation, not an order,” Sammaritano said, and strong recommendations are those “where we think, unequivocally, almost everybody should follow that recommendation. When we feel that we cannot make a strong recommendation, then we call our recommendation conditional, and it is conditional on looking at different things,” she said.
“Patients are different, especially lupus patients, and so one lupus nephritis patient may have different clinical characteristics, different thoughts about what therapy will work for them in their lives, or what therapy they really do not want to pursue,” Sammaritano said. “Maybe they can’t conceive of coming to the hospital once a month for intravenous therapy. Maybe they’re concerned about pill burden, which is something that our patient panel really emphasized to us. So, conditional recommendation means this voting panel thought that this was the best overall for most patients and most circumstances, recognizing there will still be a significant number of people, clinicians and patients, who may feel differently for that particular situation. So, that’s where you know the patient-clinician discussion can help with decision-making.”
What Are the Recommendations?
All patients with systemic lupus erythematosus (SLE) are strongly recommended to undergo proteinuria screening every 6-12 months or at the time of a flare. Those suspected of having LN should receive a prompt kidney biopsy and treatment with glucocorticoids while awaiting the biopsy and results. Two conditional recommendations for kidney biopsy include patients with SLE with unexplained impaired kidney function or a protein to creatinine ratio > 0.5 g/g, and patients with LN with a suspected flare after initial response or a lack of response or worsening after 6 months of therapy.
The guidelines include a strong recommendation for all patients with SLE to receive hydroxychloroquine and a conditional recommendation for all patients with elevated proteinuria (> 0.5 g/g) to receive renin-angiotensin-aldosterone system inhibitors (RAAS-I). Dosages in patients with LN with decreased glomerular filtration rate (GFR) should be adjusted as needed.
Sammaritano then reviewed the specifics on medication treatment. The glucocorticoid therapy in all patients with LN should begin with Pulse IV Therapy at 250-1000 mg/d for 1-3 days, followed by oral prednisone ≤ 0.5 mg/kg per day up to 40 mg/d, then tapered to a target dose > 5 mg/d within 6 months. The justification for this course comes from a 2024 systematic review finding pulse followed by oral glucocorticoids maximized complete renal response while minimizing toxicities, Sammaritano said.
“We have all become acutely aware of the very high risk of prolonged high dose of glucocorticoids for our patients,” she said, “and importantly, our patient panel participants strongly emphasized their preference for minimizing glucocorticoids dose.”
In addition to the recommendation of all patients receiving hydroxychloroquine and RAAS-I, first-line treatment of active, new-onset, or flaring LN should begin with triple therapy — glucocorticoids with two additional immunosuppressive agents. For patients with class III/IV LN, triple therapy includes the glucocorticoids course with a mycophenolic acid analog (MPAA) and either belimumab or a CNI. Conditional recommendations support MPAA with belimumab for significant extrarenal manifestations and MPAA with CNI for proteinuria ≥ 3 g/g.
An alternative triple therapy for class III/IV is glucocorticoids with low-dose cyclophosphamide and belimumab, but MPAA at 2-3 g/d is preferred over cyclophosphamide. The preferred regimen for cyclophosphamide is derived from the Euro-Lupus Nephritis Trial: Intravenous 500 mg every 2 weeks for six doses and then MPAA. Sammaritano noted that there are some limited data on using cyclophosphamide with belimumab, but “we do not specifically recommend cyclophosphamide with a CNI as one of our options because this combination has not been studied in randomized controlled trials.”
There are less data supporting class V recommendations, Sammaritano said, but for those with proteinuria of at least 1 g/g, the panel still recommends triple therapy with glucocorticoids, a MPAA, and a CNI. A CNI is preferred over belimumab because of its stabilizing effects on the podocyte cytoskeleton. Two alternative triple therapies for class V–only patients are glucocorticoids with belimumab and either low-dose cyclophosphamide or MPAA.
Dual therapy is only recommended if triple therapy is not available or not tolerated. The voting panel chose to recommend triple therapy over dual therapy with escalation for two reasons. First, the BLISS-LN and AURORA 1 trials showed improved outcomes with initial triple therapy over initial dual therapies.
Second, “nephron loss proceeds throughout a person’s lifetime even for those who do not have lupus nephritis, and every case of lupus nephritis or every period of time with uncontrolled lupus nephritis changes the course of that decline for the worse,” Sammaritano said. “So, we feel we can’t wait for nephron loss to implement what has been shown to be the most efficacious therapy. We want to gain rapid control of inflammation using the most effective regimen to prevent further damage and flare and maintain survival.”
Therapy is conditionally recommended for at least 3-5 years because “not only do we want to gain rapid control of disease activity [but we also] want to maintain control of disease activity until there’s sustained inactive disease,” Sammaritano said. “Repeat kidney biopsies show that immunologic activity persists in the kidneys for several years, and the withdrawal of immunosuppression when there is histologic activity predisposes patients to flare.” But immunosuppressive therapy can be tapered over time as determined by renal disease activity and medication tolerability.
For patients with refractory disease, consider additional factors that could be affecting the disease, such as adherence, the presence of other diagnoses, or advanced chronicity.
“If true refractory nephritis is present,” she said, “we recommend escalation to a more intensive regimen,” including the addition of anti-CD20 agents, combination therapy with three immunosuppressives, or referral for investigational therapy.
“We also emphasize the importance of other adjunctive therapies preventing comorbidities, such as cardiovascular disease, changes in bone health, or infection risk,” she said. In older patients, avoid polypharmacy as much as possible and be mindful of age-related GFR, she added.
A strong recommendation supported monitoring patients with LN and proteinuria at least every 3 months if they have not achieved complete renal response and every 3-6 months after sustained complete renal response.
Last, in patients with LN and end-stage kidney disease (ESKD), the voting panel strongly recommends transplant over dialysis and conditionally recommends proceeding to the transplant without requiring a complete clinical or serologic remission as long as no other organs are involved. In patients with LN at risk for ESKD, the guideline conditionally recommends consideration of a preemptive transplant, and patients on dialysis or post transplant are strongly recommended to regularly follow up with rheumatology.
Gabriel Kirsch, MD, a resident rheumatologist at the University of Florida College of Medicine, Jacksonville, said he found the guidelines helpful, “especially the guidance on the dichotomy between using belimumab and voclosporin and the clinical and patient preference that help you make that decision.”
Kirsch had hoped, however, to hear more about the impact of therapeutic drug monitoring of hydroxychloroquine on LN outcomes. He also noted a clinical scenario he’s come across that wasn’t addressed.
“When you’re checking GFR on these folks, a lot of our eGFR calculators are creatinine based, and creatinine at the extremes of muscle mass can be inaccurate,” such as getting artificially low creatinine readings from pediatric patients because of their low muscle mass or from patients with muscle atrophy caused by a lot of glucocorticoid exposure. “I was hoping for some more guidance on that,” he said.
Ellen Ginzler, MD, MPH, chief of rheumatology at SUNY Health Science Center in Brooklyn, New York, said the guidelines were pretty much what she expected them to be. She agreed with the panel’s advice that, when deciding between belimumab or voclosporin, “if it’s pure proteinuria, then you add voclosporin. If the patient has extra renal manifestations, you go with belimumab first.”
“They really made it quite clear that, despite the fact that people really want to reduce the amount of immunosuppression — and I agree you should taper steroids quickly — you really need to keep the immunosuppression for a prolonged period of time because all of the studies that have been done for years show that the longer you’re on immunosuppression after you achieve remission or a low disease activity state, the better your chance of not flaring,” Ginzler said. “Rapid tapering or discontinuation really increases the risk of flare.”
Sammaritano, Kirsch, and Ginzler had no disclosures. No external funding was used.
A version of this article appeared on Medscape.com.
WASHINGTON — A new guideline for management of lupus nephritis (LN) was unveiled at the annual meeting of the American College of Rheumatology (ACR), updating the 2012 LN guideline to recommend a more aggressive first-line approach to treating the disease.
“The biggest differences are that we are recommending what we’re calling triple therapy, where we incorporate the glucocorticoid therapy with baseline conventional immunosuppressants, usually mycophenolate with cyclophosphamide, and the addition of one of the newer agents more recently approved by the FDA [Food and Drug Administration] — belimumab, voclosporin, or another CNI [calcineurin inhibitor],” said Lisa Sammaritano, MD, director of the Rheumatology Reproductive Health Program of the Barbara Volcker Center for Women and Rheumatic Diseases at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medical College, both in New York City.
“This is a bit of a change from not only our previous guideline but some of the other guidelines out there, and it is based on the fact that we have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients than starting with only two agents and waiting to see if they respond before escalating therapy,” she said. Other key updates include recommending use of pulse glucocorticoid therapy with a lower dose and more rapid steroid taper and treating patients with the recommended therapy for 3-5 years.
The guiding principles of the guideline are not only to preserve kidney function and minimize morbidity and mortality but also to ensure collaborative care with nephrology, to utilize shared decision-making that includes patients’ values and preferences, to reduce healthcare disparities, and to consider pediatric and geriatric populations. The guidelines are based on a quantitative synthesis of 105 studies that yielded 7 strong recommendations, 21 conditional recommendations, and 13 good practice statements — those commonly accepted as beneficial or practical advice even if there is little direct evidence to support them. The voting panel of 19 members included not only 3 nephrologists and 2 pediatric rheumatologists but also 2 patient representatives with LN.
The recommendations are just that, “a recommendation, not an order,” Sammaritano said, and strong recommendations are those “where we think, unequivocally, almost everybody should follow that recommendation. When we feel that we cannot make a strong recommendation, then we call our recommendation conditional, and it is conditional on looking at different things,” she said.
“Patients are different, especially lupus patients, and so one lupus nephritis patient may have different clinical characteristics, different thoughts about what therapy will work for them in their lives, or what therapy they really do not want to pursue,” Sammaritano said. “Maybe they can’t conceive of coming to the hospital once a month for intravenous therapy. Maybe they’re concerned about pill burden, which is something that our patient panel really emphasized to us. So, conditional recommendation means this voting panel thought that this was the best overall for most patients and most circumstances, recognizing there will still be a significant number of people, clinicians and patients, who may feel differently for that particular situation. So, that’s where you know the patient-clinician discussion can help with decision-making.”
What Are the Recommendations?
All patients with systemic lupus erythematosus (SLE) are strongly recommended to undergo proteinuria screening every 6-12 months or at the time of a flare. Those suspected of having LN should receive a prompt kidney biopsy and treatment with glucocorticoids while awaiting the biopsy and results. Two conditional recommendations for kidney biopsy include patients with SLE with unexplained impaired kidney function or a protein to creatinine ratio > 0.5 g/g, and patients with LN with a suspected flare after initial response or a lack of response or worsening after 6 months of therapy.
The guidelines include a strong recommendation for all patients with SLE to receive hydroxychloroquine and a conditional recommendation for all patients with elevated proteinuria (> 0.5 g/g) to receive renin-angiotensin-aldosterone system inhibitors (RAAS-I). Dosages in patients with LN with decreased glomerular filtration rate (GFR) should be adjusted as needed.
Sammaritano then reviewed the specifics on medication treatment. The glucocorticoid therapy in all patients with LN should begin with Pulse IV Therapy at 250-1000 mg/d for 1-3 days, followed by oral prednisone ≤ 0.5 mg/kg per day up to 40 mg/d, then tapered to a target dose > 5 mg/d within 6 months. The justification for this course comes from a 2024 systematic review finding pulse followed by oral glucocorticoids maximized complete renal response while minimizing toxicities, Sammaritano said.
“We have all become acutely aware of the very high risk of prolonged high dose of glucocorticoids for our patients,” she said, “and importantly, our patient panel participants strongly emphasized their preference for minimizing glucocorticoids dose.”
In addition to the recommendation of all patients receiving hydroxychloroquine and RAAS-I, first-line treatment of active, new-onset, or flaring LN should begin with triple therapy — glucocorticoids with two additional immunosuppressive agents. For patients with class III/IV LN, triple therapy includes the glucocorticoids course with a mycophenolic acid analog (MPAA) and either belimumab or a CNI. Conditional recommendations support MPAA with belimumab for significant extrarenal manifestations and MPAA with CNI for proteinuria ≥ 3 g/g.
An alternative triple therapy for class III/IV is glucocorticoids with low-dose cyclophosphamide and belimumab, but MPAA at 2-3 g/d is preferred over cyclophosphamide. The preferred regimen for cyclophosphamide is derived from the Euro-Lupus Nephritis Trial: Intravenous 500 mg every 2 weeks for six doses and then MPAA. Sammaritano noted that there are some limited data on using cyclophosphamide with belimumab, but “we do not specifically recommend cyclophosphamide with a CNI as one of our options because this combination has not been studied in randomized controlled trials.”
There are less data supporting class V recommendations, Sammaritano said, but for those with proteinuria of at least 1 g/g, the panel still recommends triple therapy with glucocorticoids, a MPAA, and a CNI. A CNI is preferred over belimumab because of its stabilizing effects on the podocyte cytoskeleton. Two alternative triple therapies for class V–only patients are glucocorticoids with belimumab and either low-dose cyclophosphamide or MPAA.
Dual therapy is only recommended if triple therapy is not available or not tolerated. The voting panel chose to recommend triple therapy over dual therapy with escalation for two reasons. First, the BLISS-LN and AURORA 1 trials showed improved outcomes with initial triple therapy over initial dual therapies.
Second, “nephron loss proceeds throughout a person’s lifetime even for those who do not have lupus nephritis, and every case of lupus nephritis or every period of time with uncontrolled lupus nephritis changes the course of that decline for the worse,” Sammaritano said. “So, we feel we can’t wait for nephron loss to implement what has been shown to be the most efficacious therapy. We want to gain rapid control of inflammation using the most effective regimen to prevent further damage and flare and maintain survival.”
Therapy is conditionally recommended for at least 3-5 years because “not only do we want to gain rapid control of disease activity [but we also] want to maintain control of disease activity until there’s sustained inactive disease,” Sammaritano said. “Repeat kidney biopsies show that immunologic activity persists in the kidneys for several years, and the withdrawal of immunosuppression when there is histologic activity predisposes patients to flare.” But immunosuppressive therapy can be tapered over time as determined by renal disease activity and medication tolerability.
For patients with refractory disease, consider additional factors that could be affecting the disease, such as adherence, the presence of other diagnoses, or advanced chronicity.
“If true refractory nephritis is present,” she said, “we recommend escalation to a more intensive regimen,” including the addition of anti-CD20 agents, combination therapy with three immunosuppressives, or referral for investigational therapy.
“We also emphasize the importance of other adjunctive therapies preventing comorbidities, such as cardiovascular disease, changes in bone health, or infection risk,” she said. In older patients, avoid polypharmacy as much as possible and be mindful of age-related GFR, she added.
A strong recommendation supported monitoring patients with LN and proteinuria at least every 3 months if they have not achieved complete renal response and every 3-6 months after sustained complete renal response.
Last, in patients with LN and end-stage kidney disease (ESKD), the voting panel strongly recommends transplant over dialysis and conditionally recommends proceeding to the transplant without requiring a complete clinical or serologic remission as long as no other organs are involved. In patients with LN at risk for ESKD, the guideline conditionally recommends consideration of a preemptive transplant, and patients on dialysis or post transplant are strongly recommended to regularly follow up with rheumatology.
Gabriel Kirsch, MD, a resident rheumatologist at the University of Florida College of Medicine, Jacksonville, said he found the guidelines helpful, “especially the guidance on the dichotomy between using belimumab and voclosporin and the clinical and patient preference that help you make that decision.”
Kirsch had hoped, however, to hear more about the impact of therapeutic drug monitoring of hydroxychloroquine on LN outcomes. He also noted a clinical scenario he’s come across that wasn’t addressed.
“When you’re checking GFR on these folks, a lot of our eGFR calculators are creatinine based, and creatinine at the extremes of muscle mass can be inaccurate,” such as getting artificially low creatinine readings from pediatric patients because of their low muscle mass or from patients with muscle atrophy caused by a lot of glucocorticoid exposure. “I was hoping for some more guidance on that,” he said.
Ellen Ginzler, MD, MPH, chief of rheumatology at SUNY Health Science Center in Brooklyn, New York, said the guidelines were pretty much what she expected them to be. She agreed with the panel’s advice that, when deciding between belimumab or voclosporin, “if it’s pure proteinuria, then you add voclosporin. If the patient has extra renal manifestations, you go with belimumab first.”
“They really made it quite clear that, despite the fact that people really want to reduce the amount of immunosuppression — and I agree you should taper steroids quickly — you really need to keep the immunosuppression for a prolonged period of time because all of the studies that have been done for years show that the longer you’re on immunosuppression after you achieve remission or a low disease activity state, the better your chance of not flaring,” Ginzler said. “Rapid tapering or discontinuation really increases the risk of flare.”
Sammaritano, Kirsch, and Ginzler had no disclosures. No external funding was used.
A version of this article appeared on Medscape.com.
WASHINGTON — A new guideline for management of lupus nephritis (LN) was unveiled at the annual meeting of the American College of Rheumatology (ACR), updating the 2012 LN guideline to recommend a more aggressive first-line approach to treating the disease.
“The biggest differences are that we are recommending what we’re calling triple therapy, where we incorporate the glucocorticoid therapy with baseline conventional immunosuppressants, usually mycophenolate with cyclophosphamide, and the addition of one of the newer agents more recently approved by the FDA [Food and Drug Administration] — belimumab, voclosporin, or another CNI [calcineurin inhibitor],” said Lisa Sammaritano, MD, director of the Rheumatology Reproductive Health Program of the Barbara Volcker Center for Women and Rheumatic Diseases at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medical College, both in New York City.
“This is a bit of a change from not only our previous guideline but some of the other guidelines out there, and it is based on the fact that we have very convincing evidence that starting with triple therapy yields to better long-term outcomes for our patients than starting with only two agents and waiting to see if they respond before escalating therapy,” she said. Other key updates include recommending use of pulse glucocorticoid therapy with a lower dose and more rapid steroid taper and treating patients with the recommended therapy for 3-5 years.
The guiding principles of the guideline are not only to preserve kidney function and minimize morbidity and mortality but also to ensure collaborative care with nephrology, to utilize shared decision-making that includes patients’ values and preferences, to reduce healthcare disparities, and to consider pediatric and geriatric populations. The guidelines are based on a quantitative synthesis of 105 studies that yielded 7 strong recommendations, 21 conditional recommendations, and 13 good practice statements — those commonly accepted as beneficial or practical advice even if there is little direct evidence to support them. The voting panel of 19 members included not only 3 nephrologists and 2 pediatric rheumatologists but also 2 patient representatives with LN.
The recommendations are just that, “a recommendation, not an order,” Sammaritano said, and strong recommendations are those “where we think, unequivocally, almost everybody should follow that recommendation. When we feel that we cannot make a strong recommendation, then we call our recommendation conditional, and it is conditional on looking at different things,” she said.
“Patients are different, especially lupus patients, and so one lupus nephritis patient may have different clinical characteristics, different thoughts about what therapy will work for them in their lives, or what therapy they really do not want to pursue,” Sammaritano said. “Maybe they can’t conceive of coming to the hospital once a month for intravenous therapy. Maybe they’re concerned about pill burden, which is something that our patient panel really emphasized to us. So, conditional recommendation means this voting panel thought that this was the best overall for most patients and most circumstances, recognizing there will still be a significant number of people, clinicians and patients, who may feel differently for that particular situation. So, that’s where you know the patient-clinician discussion can help with decision-making.”
What Are the Recommendations?
All patients with systemic lupus erythematosus (SLE) are strongly recommended to undergo proteinuria screening every 6-12 months or at the time of a flare. Those suspected of having LN should receive a prompt kidney biopsy and treatment with glucocorticoids while awaiting the biopsy and results. Two conditional recommendations for kidney biopsy include patients with SLE with unexplained impaired kidney function or a protein to creatinine ratio > 0.5 g/g, and patients with LN with a suspected flare after initial response or a lack of response or worsening after 6 months of therapy.
The guidelines include a strong recommendation for all patients with SLE to receive hydroxychloroquine and a conditional recommendation for all patients with elevated proteinuria (> 0.5 g/g) to receive renin-angiotensin-aldosterone system inhibitors (RAAS-I). Dosages in patients with LN with decreased glomerular filtration rate (GFR) should be adjusted as needed.
Sammaritano then reviewed the specifics on medication treatment. The glucocorticoid therapy in all patients with LN should begin with Pulse IV Therapy at 250-1000 mg/d for 1-3 days, followed by oral prednisone ≤ 0.5 mg/kg per day up to 40 mg/d, then tapered to a target dose > 5 mg/d within 6 months. The justification for this course comes from a 2024 systematic review finding pulse followed by oral glucocorticoids maximized complete renal response while minimizing toxicities, Sammaritano said.
“We have all become acutely aware of the very high risk of prolonged high dose of glucocorticoids for our patients,” she said, “and importantly, our patient panel participants strongly emphasized their preference for minimizing glucocorticoids dose.”
In addition to the recommendation of all patients receiving hydroxychloroquine and RAAS-I, first-line treatment of active, new-onset, or flaring LN should begin with triple therapy — glucocorticoids with two additional immunosuppressive agents. For patients with class III/IV LN, triple therapy includes the glucocorticoids course with a mycophenolic acid analog (MPAA) and either belimumab or a CNI. Conditional recommendations support MPAA with belimumab for significant extrarenal manifestations and MPAA with CNI for proteinuria ≥ 3 g/g.
An alternative triple therapy for class III/IV is glucocorticoids with low-dose cyclophosphamide and belimumab, but MPAA at 2-3 g/d is preferred over cyclophosphamide. The preferred regimen for cyclophosphamide is derived from the Euro-Lupus Nephritis Trial: Intravenous 500 mg every 2 weeks for six doses and then MPAA. Sammaritano noted that there are some limited data on using cyclophosphamide with belimumab, but “we do not specifically recommend cyclophosphamide with a CNI as one of our options because this combination has not been studied in randomized controlled trials.”
There are less data supporting class V recommendations, Sammaritano said, but for those with proteinuria of at least 1 g/g, the panel still recommends triple therapy with glucocorticoids, a MPAA, and a CNI. A CNI is preferred over belimumab because of its stabilizing effects on the podocyte cytoskeleton. Two alternative triple therapies for class V–only patients are glucocorticoids with belimumab and either low-dose cyclophosphamide or MPAA.
Dual therapy is only recommended if triple therapy is not available or not tolerated. The voting panel chose to recommend triple therapy over dual therapy with escalation for two reasons. First, the BLISS-LN and AURORA 1 trials showed improved outcomes with initial triple therapy over initial dual therapies.
Second, “nephron loss proceeds throughout a person’s lifetime even for those who do not have lupus nephritis, and every case of lupus nephritis or every period of time with uncontrolled lupus nephritis changes the course of that decline for the worse,” Sammaritano said. “So, we feel we can’t wait for nephron loss to implement what has been shown to be the most efficacious therapy. We want to gain rapid control of inflammation using the most effective regimen to prevent further damage and flare and maintain survival.”
Therapy is conditionally recommended for at least 3-5 years because “not only do we want to gain rapid control of disease activity [but we also] want to maintain control of disease activity until there’s sustained inactive disease,” Sammaritano said. “Repeat kidney biopsies show that immunologic activity persists in the kidneys for several years, and the withdrawal of immunosuppression when there is histologic activity predisposes patients to flare.” But immunosuppressive therapy can be tapered over time as determined by renal disease activity and medication tolerability.
For patients with refractory disease, consider additional factors that could be affecting the disease, such as adherence, the presence of other diagnoses, or advanced chronicity.
“If true refractory nephritis is present,” she said, “we recommend escalation to a more intensive regimen,” including the addition of anti-CD20 agents, combination therapy with three immunosuppressives, or referral for investigational therapy.
“We also emphasize the importance of other adjunctive therapies preventing comorbidities, such as cardiovascular disease, changes in bone health, or infection risk,” she said. In older patients, avoid polypharmacy as much as possible and be mindful of age-related GFR, she added.
A strong recommendation supported monitoring patients with LN and proteinuria at least every 3 months if they have not achieved complete renal response and every 3-6 months after sustained complete renal response.
Last, in patients with LN and end-stage kidney disease (ESKD), the voting panel strongly recommends transplant over dialysis and conditionally recommends proceeding to the transplant without requiring a complete clinical or serologic remission as long as no other organs are involved. In patients with LN at risk for ESKD, the guideline conditionally recommends consideration of a preemptive transplant, and patients on dialysis or post transplant are strongly recommended to regularly follow up with rheumatology.
Gabriel Kirsch, MD, a resident rheumatologist at the University of Florida College of Medicine, Jacksonville, said he found the guidelines helpful, “especially the guidance on the dichotomy between using belimumab and voclosporin and the clinical and patient preference that help you make that decision.”
Kirsch had hoped, however, to hear more about the impact of therapeutic drug monitoring of hydroxychloroquine on LN outcomes. He also noted a clinical scenario he’s come across that wasn’t addressed.
“When you’re checking GFR on these folks, a lot of our eGFR calculators are creatinine based, and creatinine at the extremes of muscle mass can be inaccurate,” such as getting artificially low creatinine readings from pediatric patients because of their low muscle mass or from patients with muscle atrophy caused by a lot of glucocorticoid exposure. “I was hoping for some more guidance on that,” he said.
Ellen Ginzler, MD, MPH, chief of rheumatology at SUNY Health Science Center in Brooklyn, New York, said the guidelines were pretty much what she expected them to be. She agreed with the panel’s advice that, when deciding between belimumab or voclosporin, “if it’s pure proteinuria, then you add voclosporin. If the patient has extra renal manifestations, you go with belimumab first.”
“They really made it quite clear that, despite the fact that people really want to reduce the amount of immunosuppression — and I agree you should taper steroids quickly — you really need to keep the immunosuppression for a prolonged period of time because all of the studies that have been done for years show that the longer you’re on immunosuppression after you achieve remission or a low disease activity state, the better your chance of not flaring,” Ginzler said. “Rapid tapering or discontinuation really increases the risk of flare.”
Sammaritano, Kirsch, and Ginzler had no disclosures. No external funding was used.
A version of this article appeared on Medscape.com.
FROM ACR 2024
Commentary: Predicting PsA Progression, Managing Comorbidities, and Evaluating New Therapies, December 2024
Recently published clinical research in psoriatic arthritis (PsA) has continued to focus on the transition from psoriasis to PsA, comorbidities, and effects of treatments. Garcia-Salinas and colleagues reported results of a large study that investigated 1419 patients with joint pain who were carefully clinically evaluated with imaging (ultrasonography and MRI) and laboratory tests. They found that among patients with arthralgia, 8.4% were at risk of developing PsA (ie, had a personal or family history of psoriasis), with 29% of these patients progressing to PsA within 1 year. Significant predictors of progression included a family history of psoriasis, synovitis detected by power Doppler ultrasound, enthesopathy on ultrasonography, and a low tender joint count. Thus, more than one quarter of patients with psoriasis and joint pain developed PsA in 1 year. Patients with psoriasis and joint pain, especially those with findings on imaging, should be referred to rheumatologists and carefully followed up for early diagnosis of PsA and therefore better outcomes.
Chronic kidney disease (CKD) is a known comorbidity in psoriatic disease but is less well characterised. In a prospective observational cohort study that included 1336 patients with PsA, Kharouf and colleagues reported that 123 (9.2%) had CKD. They demonstrated that diabetes, kidney stones, joint damage, high uric acid levels, and daily use of nonsteroidal anti-inflammatory drugs were associated with development of CKD, whereas methotrexate use had a renoprotective effect. Thus, patients with severe PsA and comorbidities such as diabetes are at higher risk for CKD. Better management of PsA using disease-modifying antirheumatic drugs may reduce the risk. Replication of these findings, especially in terms of the renoprotective effect of methotrexate, is required.
Patients with PsA who do not respond to treatment with tumour necrosis factor (TNF) inhibitors are generally less likely to respond to subsequent therapy. Evaluating newer modes of action in this treatment-resistant PsA population is important. COSMOS was a phase 3b trial that included 285 patients with PsA who had inadequate response or intolerance to TNF inhibitors and were randomly assigned to receive 100 mg guselkumab (a monoclonal antibody targeting interleukin-23; n = 189) or placebo (n = 96). In a post hoc analysis, Gossec and colleagues showed that at week 24, a greater proportion of patients receiving guselkumab vs placebo achieved minimal disease activity (MDA) (14.8% vs 3.1%). Most of the patients who achieved MDA at week 24 maintained the response at week 48. Thus, guselkumab treatment led to sustained MDA over 1 year in patients with PsA who had inadequate response or intolerance to TNF inhibitors.
Achieving MDA was also evaluated in another novel drug for PsA. Deucravacitinib is an oral TYK2 inhibitor that is approved for the treatment of psoriasis and is currently being evaluated in phase 3 PsA trials. In a post hoc analysis of a phase 2 trial that included 203 adults with PsA who did not respond to or were intolerant to one or more prior therapies and were randomly assigned to receive 6 mg or 12 mg deucravacitinib or placebo, Kavanaugh and colleagues found that after 16 weeks, a significantly higher proportion of patients treated with deucravacitinib vs placebo achieved MDA (6 mg: 22.9% vs 7.6%; P = .01 and 12 mg: 23.9% vs 7.6%; P = .007). Achieving MDA reflects a state of low disease activity or remission; therefore, these results are very encouraging. Results from phase 3 trials and a formal comparison with other drugs will inform rheumatologists about the place of deucravacitinib in the management of PsA.
Recently published clinical research in psoriatic arthritis (PsA) has continued to focus on the transition from psoriasis to PsA, comorbidities, and effects of treatments. Garcia-Salinas and colleagues reported results of a large study that investigated 1419 patients with joint pain who were carefully clinically evaluated with imaging (ultrasonography and MRI) and laboratory tests. They found that among patients with arthralgia, 8.4% were at risk of developing PsA (ie, had a personal or family history of psoriasis), with 29% of these patients progressing to PsA within 1 year. Significant predictors of progression included a family history of psoriasis, synovitis detected by power Doppler ultrasound, enthesopathy on ultrasonography, and a low tender joint count. Thus, more than one quarter of patients with psoriasis and joint pain developed PsA in 1 year. Patients with psoriasis and joint pain, especially those with findings on imaging, should be referred to rheumatologists and carefully followed up for early diagnosis of PsA and therefore better outcomes.
Chronic kidney disease (CKD) is a known comorbidity in psoriatic disease but is less well characterised. In a prospective observational cohort study that included 1336 patients with PsA, Kharouf and colleagues reported that 123 (9.2%) had CKD. They demonstrated that diabetes, kidney stones, joint damage, high uric acid levels, and daily use of nonsteroidal anti-inflammatory drugs were associated with development of CKD, whereas methotrexate use had a renoprotective effect. Thus, patients with severe PsA and comorbidities such as diabetes are at higher risk for CKD. Better management of PsA using disease-modifying antirheumatic drugs may reduce the risk. Replication of these findings, especially in terms of the renoprotective effect of methotrexate, is required.
Patients with PsA who do not respond to treatment with tumour necrosis factor (TNF) inhibitors are generally less likely to respond to subsequent therapy. Evaluating newer modes of action in this treatment-resistant PsA population is important. COSMOS was a phase 3b trial that included 285 patients with PsA who had inadequate response or intolerance to TNF inhibitors and were randomly assigned to receive 100 mg guselkumab (a monoclonal antibody targeting interleukin-23; n = 189) or placebo (n = 96). In a post hoc analysis, Gossec and colleagues showed that at week 24, a greater proportion of patients receiving guselkumab vs placebo achieved minimal disease activity (MDA) (14.8% vs 3.1%). Most of the patients who achieved MDA at week 24 maintained the response at week 48. Thus, guselkumab treatment led to sustained MDA over 1 year in patients with PsA who had inadequate response or intolerance to TNF inhibitors.
Achieving MDA was also evaluated in another novel drug for PsA. Deucravacitinib is an oral TYK2 inhibitor that is approved for the treatment of psoriasis and is currently being evaluated in phase 3 PsA trials. In a post hoc analysis of a phase 2 trial that included 203 adults with PsA who did not respond to or were intolerant to one or more prior therapies and were randomly assigned to receive 6 mg or 12 mg deucravacitinib or placebo, Kavanaugh and colleagues found that after 16 weeks, a significantly higher proportion of patients treated with deucravacitinib vs placebo achieved MDA (6 mg: 22.9% vs 7.6%; P = .01 and 12 mg: 23.9% vs 7.6%; P = .007). Achieving MDA reflects a state of low disease activity or remission; therefore, these results are very encouraging. Results from phase 3 trials and a formal comparison with other drugs will inform rheumatologists about the place of deucravacitinib in the management of PsA.
Recently published clinical research in psoriatic arthritis (PsA) has continued to focus on the transition from psoriasis to PsA, comorbidities, and effects of treatments. Garcia-Salinas and colleagues reported results of a large study that investigated 1419 patients with joint pain who were carefully clinically evaluated with imaging (ultrasonography and MRI) and laboratory tests. They found that among patients with arthralgia, 8.4% were at risk of developing PsA (ie, had a personal or family history of psoriasis), with 29% of these patients progressing to PsA within 1 year. Significant predictors of progression included a family history of psoriasis, synovitis detected by power Doppler ultrasound, enthesopathy on ultrasonography, and a low tender joint count. Thus, more than one quarter of patients with psoriasis and joint pain developed PsA in 1 year. Patients with psoriasis and joint pain, especially those with findings on imaging, should be referred to rheumatologists and carefully followed up for early diagnosis of PsA and therefore better outcomes.
Chronic kidney disease (CKD) is a known comorbidity in psoriatic disease but is less well characterised. In a prospective observational cohort study that included 1336 patients with PsA, Kharouf and colleagues reported that 123 (9.2%) had CKD. They demonstrated that diabetes, kidney stones, joint damage, high uric acid levels, and daily use of nonsteroidal anti-inflammatory drugs were associated with development of CKD, whereas methotrexate use had a renoprotective effect. Thus, patients with severe PsA and comorbidities such as diabetes are at higher risk for CKD. Better management of PsA using disease-modifying antirheumatic drugs may reduce the risk. Replication of these findings, especially in terms of the renoprotective effect of methotrexate, is required.
Patients with PsA who do not respond to treatment with tumour necrosis factor (TNF) inhibitors are generally less likely to respond to subsequent therapy. Evaluating newer modes of action in this treatment-resistant PsA population is important. COSMOS was a phase 3b trial that included 285 patients with PsA who had inadequate response or intolerance to TNF inhibitors and were randomly assigned to receive 100 mg guselkumab (a monoclonal antibody targeting interleukin-23; n = 189) or placebo (n = 96). In a post hoc analysis, Gossec and colleagues showed that at week 24, a greater proportion of patients receiving guselkumab vs placebo achieved minimal disease activity (MDA) (14.8% vs 3.1%). Most of the patients who achieved MDA at week 24 maintained the response at week 48. Thus, guselkumab treatment led to sustained MDA over 1 year in patients with PsA who had inadequate response or intolerance to TNF inhibitors.
Achieving MDA was also evaluated in another novel drug for PsA. Deucravacitinib is an oral TYK2 inhibitor that is approved for the treatment of psoriasis and is currently being evaluated in phase 3 PsA trials. In a post hoc analysis of a phase 2 trial that included 203 adults with PsA who did not respond to or were intolerant to one or more prior therapies and were randomly assigned to receive 6 mg or 12 mg deucravacitinib or placebo, Kavanaugh and colleagues found that after 16 weeks, a significantly higher proportion of patients treated with deucravacitinib vs placebo achieved MDA (6 mg: 22.9% vs 7.6%; P = .01 and 12 mg: 23.9% vs 7.6%; P = .007). Achieving MDA reflects a state of low disease activity or remission; therefore, these results are very encouraging. Results from phase 3 trials and a formal comparison with other drugs will inform rheumatologists about the place of deucravacitinib in the management of PsA.
Guselkumab Lowers Serum Biomarker Levels and Improves Disease Activity in Biologic-Naive PsA Patients
Key clinical point: Guselkumab significantly reduced inflammatory and collagen biomarker levels, correlating with improvements in joint and overall disease activity over 2 years in biologic-naive patients with psoriatic arthritis (PsA).
Major finding: Over 2 years, reductions in C-reactive protein, interleukin-6, matrix metalloproteinase (MMP)–degradation type 1 collagen (C1M), and MMP-degradation type VI collagen (C6M) levels correlated with improved Disease Activity in Psoriatic Arthritis (correlation coefficient [r], 0.26-0.30; P < .05). Additionally, reductions in C1M, MMP-degradation type III collagen, MMP-degradation type IV collagen, and C6M levels correlated with improved Psoriatic Arthritis Disease Activity Scores (r, 0.27-0.31; P < .05).
Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 739 biologic-naive patients with active PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with a crossover to 100 mg guselkumab every 4 weeks at week 24.
Disclosures: This DISCOVER-2 study was funded by Janssen Research & Development, LLC. Four authors reported being employees of Janssen and owning stock or stock options in Johnson & Johnson. Others declared having ties with various sources.
Source: Siebert S, Schett G, Raychaudhuri SP, et al. Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: Results from a phase III randomized controlled trial. Ther Adv Musculoskelet Dis. 2024;16:1-20. Source
Key clinical point: Guselkumab significantly reduced inflammatory and collagen biomarker levels, correlating with improvements in joint and overall disease activity over 2 years in biologic-naive patients with psoriatic arthritis (PsA).
Major finding: Over 2 years, reductions in C-reactive protein, interleukin-6, matrix metalloproteinase (MMP)–degradation type 1 collagen (C1M), and MMP-degradation type VI collagen (C6M) levels correlated with improved Disease Activity in Psoriatic Arthritis (correlation coefficient [r], 0.26-0.30; P < .05). Additionally, reductions in C1M, MMP-degradation type III collagen, MMP-degradation type IV collagen, and C6M levels correlated with improved Psoriatic Arthritis Disease Activity Scores (r, 0.27-0.31; P < .05).
Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 739 biologic-naive patients with active PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with a crossover to 100 mg guselkumab every 4 weeks at week 24.
Disclosures: This DISCOVER-2 study was funded by Janssen Research & Development, LLC. Four authors reported being employees of Janssen and owning stock or stock options in Johnson & Johnson. Others declared having ties with various sources.
Source: Siebert S, Schett G, Raychaudhuri SP, et al. Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: Results from a phase III randomized controlled trial. Ther Adv Musculoskelet Dis. 2024;16:1-20. Source
Key clinical point: Guselkumab significantly reduced inflammatory and collagen biomarker levels, correlating with improvements in joint and overall disease activity over 2 years in biologic-naive patients with psoriatic arthritis (PsA).
Major finding: Over 2 years, reductions in C-reactive protein, interleukin-6, matrix metalloproteinase (MMP)–degradation type 1 collagen (C1M), and MMP-degradation type VI collagen (C6M) levels correlated with improved Disease Activity in Psoriatic Arthritis (correlation coefficient [r], 0.26-0.30; P < .05). Additionally, reductions in C1M, MMP-degradation type III collagen, MMP-degradation type IV collagen, and C6M levels correlated with improved Psoriatic Arthritis Disease Activity Scores (r, 0.27-0.31; P < .05).
Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 739 biologic-naive patients with active PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with a crossover to 100 mg guselkumab every 4 weeks at week 24.
Disclosures: This DISCOVER-2 study was funded by Janssen Research & Development, LLC. Four authors reported being employees of Janssen and owning stock or stock options in Johnson & Johnson. Others declared having ties with various sources.
Source: Siebert S, Schett G, Raychaudhuri SP, et al. Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: Results from a phase III randomized controlled trial. Ther Adv Musculoskelet Dis. 2024;16:1-20. Source
Predictors of Treatment Response to b/tsDMARDs in PsA
Key clinical point: Among patients with psoriatic arthritis (PsA), men and those with elevated baseline C-reactive protein (CRP) levels showed an improved response to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), whereas older patients and those with severe baseline disease activity showed a worse response.
Major finding: Among patients with PsA, men (odds ratio [OR], 2.188; 95% CI, 1.912-2.503) and those with elevated baseline CRP levels (OR, 1.537; 95% CI, 1.111-2.125) showed an improved response to b/tsDMARDs. Conversely, older patients (OR, 0.982; 95% CI, 0.975-0.99) and those with increased baseline Disease Activity in Psoriatic Arthritis (OR, 0.789; 95% CI, 0.663-0.938), Health Assessment Questionnaire (OR, 0.483; 95% CI, 0.336-0.696), and joint count (OR, 0.97; 95% CI, 0.945-0.996) scores showed a significantly worse b/tsDMARD response.
Study details: This systematic review and meta-analysis of 37 studies included 17,042 patients with PsA.
Disclosures: Open access funding was provided by the University of Zurich. This study did not receive any funding. The authors declared no conflicts of interest.
Source: Künzler T, Bamert M, Sprott H. Factors predicting treatment response to biological and targeted synthetic disease-modifying antirheumatic drugs in psoriatic arthritis—A systematic review and meta-analysis. Clin Rheumatol. Published online October 28, 2024. Source
Key clinical point: Among patients with psoriatic arthritis (PsA), men and those with elevated baseline C-reactive protein (CRP) levels showed an improved response to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), whereas older patients and those with severe baseline disease activity showed a worse response.
Major finding: Among patients with PsA, men (odds ratio [OR], 2.188; 95% CI, 1.912-2.503) and those with elevated baseline CRP levels (OR, 1.537; 95% CI, 1.111-2.125) showed an improved response to b/tsDMARDs. Conversely, older patients (OR, 0.982; 95% CI, 0.975-0.99) and those with increased baseline Disease Activity in Psoriatic Arthritis (OR, 0.789; 95% CI, 0.663-0.938), Health Assessment Questionnaire (OR, 0.483; 95% CI, 0.336-0.696), and joint count (OR, 0.97; 95% CI, 0.945-0.996) scores showed a significantly worse b/tsDMARD response.
Study details: This systematic review and meta-analysis of 37 studies included 17,042 patients with PsA.
Disclosures: Open access funding was provided by the University of Zurich. This study did not receive any funding. The authors declared no conflicts of interest.
Source: Künzler T, Bamert M, Sprott H. Factors predicting treatment response to biological and targeted synthetic disease-modifying antirheumatic drugs in psoriatic arthritis—A systematic review and meta-analysis. Clin Rheumatol. Published online October 28, 2024. Source
Key clinical point: Among patients with psoriatic arthritis (PsA), men and those with elevated baseline C-reactive protein (CRP) levels showed an improved response to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), whereas older patients and those with severe baseline disease activity showed a worse response.
Major finding: Among patients with PsA, men (odds ratio [OR], 2.188; 95% CI, 1.912-2.503) and those with elevated baseline CRP levels (OR, 1.537; 95% CI, 1.111-2.125) showed an improved response to b/tsDMARDs. Conversely, older patients (OR, 0.982; 95% CI, 0.975-0.99) and those with increased baseline Disease Activity in Psoriatic Arthritis (OR, 0.789; 95% CI, 0.663-0.938), Health Assessment Questionnaire (OR, 0.483; 95% CI, 0.336-0.696), and joint count (OR, 0.97; 95% CI, 0.945-0.996) scores showed a significantly worse b/tsDMARD response.
Study details: This systematic review and meta-analysis of 37 studies included 17,042 patients with PsA.
Disclosures: Open access funding was provided by the University of Zurich. This study did not receive any funding. The authors declared no conflicts of interest.
Source: Künzler T, Bamert M, Sprott H. Factors predicting treatment response to biological and targeted synthetic disease-modifying antirheumatic drugs in psoriatic arthritis—A systematic review and meta-analysis. Clin Rheumatol. Published online October 28, 2024. Source
Real-World Study Shows Severity of Psoriasis Linked to Enthesitis in PsA
Key clinical point: The severity of psoriasis was associated with enthesitis in patients with psoriatic arthritis (PsA) and psoriasis, particularly in older patients and those with a longer history of psoriasis.
Major finding: The severity of psoriasis, as assessed using the Psoriasis Area and Severity Index, was significantly associated with enthesitis (correlation coefficient [ρ], 0.285; P = .013). The association remained significant after adjusting for age (ρ, 0.274; P = .043) and the duration of PsA (ρ, 0.302; P = .027).
Study details: This observational study included 76 adults diagnosed with PsA and psoriasis, comprising 42 men and 34 women.
Disclosures: This study was conducted within the project "Psoriatic arthritis—epidemiology and risk factors of progression" of the Ministry of Health, Education and Sports, Republic of Croatia. No conflicts of interest were reported in this study.
Source: Grazio S, Šitum M, Grubišić F, et al. Association of enthesitis with severity of psoriasis in psoriatic arthritis: An observational study. Rheumatol Int. Published online October 15, 2024. Source
Key clinical point: The severity of psoriasis was associated with enthesitis in patients with psoriatic arthritis (PsA) and psoriasis, particularly in older patients and those with a longer history of psoriasis.
Major finding: The severity of psoriasis, as assessed using the Psoriasis Area and Severity Index, was significantly associated with enthesitis (correlation coefficient [ρ], 0.285; P = .013). The association remained significant after adjusting for age (ρ, 0.274; P = .043) and the duration of PsA (ρ, 0.302; P = .027).
Study details: This observational study included 76 adults diagnosed with PsA and psoriasis, comprising 42 men and 34 women.
Disclosures: This study was conducted within the project "Psoriatic arthritis—epidemiology and risk factors of progression" of the Ministry of Health, Education and Sports, Republic of Croatia. No conflicts of interest were reported in this study.
Source: Grazio S, Šitum M, Grubišić F, et al. Association of enthesitis with severity of psoriasis in psoriatic arthritis: An observational study. Rheumatol Int. Published online October 15, 2024. Source
Key clinical point: The severity of psoriasis was associated with enthesitis in patients with psoriatic arthritis (PsA) and psoriasis, particularly in older patients and those with a longer history of psoriasis.
Major finding: The severity of psoriasis, as assessed using the Psoriasis Area and Severity Index, was significantly associated with enthesitis (correlation coefficient [ρ], 0.285; P = .013). The association remained significant after adjusting for age (ρ, 0.274; P = .043) and the duration of PsA (ρ, 0.302; P = .027).
Study details: This observational study included 76 adults diagnosed with PsA and psoriasis, comprising 42 men and 34 women.
Disclosures: This study was conducted within the project "Psoriatic arthritis—epidemiology and risk factors of progression" of the Ministry of Health, Education and Sports, Republic of Croatia. No conflicts of interest were reported in this study.
Source: Grazio S, Šitum M, Grubišić F, et al. Association of enthesitis with severity of psoriasis in psoriatic arthritis: An observational study. Rheumatol Int. Published online October 15, 2024. Source
Depressive Symptoms Lower the Likelihood of Remission in PsA
Key clinical point: The presence of depressive symptoms within the first 2 years after diagnosis in patients with psoriatic arthritis (PsA) was associated with a decreased likelihood of achieving remission.
Major finding: Overall, 18% patients with PsA had possible depression. During 2 years of follow-up, depression was associated with decreased odds of achieving remission (adjusted odds ratio, 0.24; 95% CI, 0.08-0.71). The presence of depression was also associated with an increased tender joint count, worse general health, and increased pain.
Study details: This study included data from the Dutch Southwest Early Psoriatic Arthritis Cohort study, a prospective cohort study that included 367 patients with PsA, and the Rotterdam Early Arthritis Cohort trial, which included 400 patients with rheumatoid arthritis.
Disclosures: This study was supported by unrestricted grants from ZonMW, Pfizer, and Abbvie B.V. The authors declared no conflicts of interest.
Source: Snoeck Henkemans SVJ, Vis M, Koc GH, et al. Association between depression and anxiety and inability to achieve remission in rheumatoid arthritis and psoriatic arthritis. Rheumatology (Oxford). Published online November 6, 2024. Source
Key clinical point: The presence of depressive symptoms within the first 2 years after diagnosis in patients with psoriatic arthritis (PsA) was associated with a decreased likelihood of achieving remission.
Major finding: Overall, 18% patients with PsA had possible depression. During 2 years of follow-up, depression was associated with decreased odds of achieving remission (adjusted odds ratio, 0.24; 95% CI, 0.08-0.71). The presence of depression was also associated with an increased tender joint count, worse general health, and increased pain.
Study details: This study included data from the Dutch Southwest Early Psoriatic Arthritis Cohort study, a prospective cohort study that included 367 patients with PsA, and the Rotterdam Early Arthritis Cohort trial, which included 400 patients with rheumatoid arthritis.
Disclosures: This study was supported by unrestricted grants from ZonMW, Pfizer, and Abbvie B.V. The authors declared no conflicts of interest.
Source: Snoeck Henkemans SVJ, Vis M, Koc GH, et al. Association between depression and anxiety and inability to achieve remission in rheumatoid arthritis and psoriatic arthritis. Rheumatology (Oxford). Published online November 6, 2024. Source
Key clinical point: The presence of depressive symptoms within the first 2 years after diagnosis in patients with psoriatic arthritis (PsA) was associated with a decreased likelihood of achieving remission.
Major finding: Overall, 18% patients with PsA had possible depression. During 2 years of follow-up, depression was associated with decreased odds of achieving remission (adjusted odds ratio, 0.24; 95% CI, 0.08-0.71). The presence of depression was also associated with an increased tender joint count, worse general health, and increased pain.
Study details: This study included data from the Dutch Southwest Early Psoriatic Arthritis Cohort study, a prospective cohort study that included 367 patients with PsA, and the Rotterdam Early Arthritis Cohort trial, which included 400 patients with rheumatoid arthritis.
Disclosures: This study was supported by unrestricted grants from ZonMW, Pfizer, and Abbvie B.V. The authors declared no conflicts of interest.
Source: Snoeck Henkemans SVJ, Vis M, Koc GH, et al. Association between depression and anxiety and inability to achieve remission in rheumatoid arthritis and psoriatic arthritis. Rheumatology (Oxford). Published online November 6, 2024. Source
Identifying Predictors of Psoriatic Arthritis Progression in Patients with Arthralgia
Key clinical point: The significant predictors of developing psoriatic arthritis (PsA) in patients with arthralgia include a family history of psoriasis, synovitis, enthesopathy, and a low tender joint count.
Major finding: Among patients with arthralgia, 8.4% were at a risk of developing PsA, with 29% of these patients progressing to PsA within 1 year. Significant predictors of progression included a family history of psoriasis (odds ratio [OR], 32; 95% CI, 1.2-1026), synovitis detected by Power Doppler ultrasound (OR, 31; 95% CI, 1.1-967), enthesopathy findings on ultrasound (OR, 75; 95% CI, 13-710), and a low tender joint count (OR, 0.2; 95% CI, 0.05-0.6).
Study details: This prospective longitudinal study included 1419 patients with arthralgia who were older than 18 years of age.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Garcia-Salinas R, Magri S, Mareco J, et al. Arthralgia with risk of progression to psoriatic arthritis: Role of clinical assessments and ultrasound as prognostic factors. Rheumatology (Oxford). Published online October 15, 2024. Source
Key clinical point: The significant predictors of developing psoriatic arthritis (PsA) in patients with arthralgia include a family history of psoriasis, synovitis, enthesopathy, and a low tender joint count.
Major finding: Among patients with arthralgia, 8.4% were at a risk of developing PsA, with 29% of these patients progressing to PsA within 1 year. Significant predictors of progression included a family history of psoriasis (odds ratio [OR], 32; 95% CI, 1.2-1026), synovitis detected by Power Doppler ultrasound (OR, 31; 95% CI, 1.1-967), enthesopathy findings on ultrasound (OR, 75; 95% CI, 13-710), and a low tender joint count (OR, 0.2; 95% CI, 0.05-0.6).
Study details: This prospective longitudinal study included 1419 patients with arthralgia who were older than 18 years of age.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Garcia-Salinas R, Magri S, Mareco J, et al. Arthralgia with risk of progression to psoriatic arthritis: Role of clinical assessments and ultrasound as prognostic factors. Rheumatology (Oxford). Published online October 15, 2024. Source
Key clinical point: The significant predictors of developing psoriatic arthritis (PsA) in patients with arthralgia include a family history of psoriasis, synovitis, enthesopathy, and a low tender joint count.
Major finding: Among patients with arthralgia, 8.4% were at a risk of developing PsA, with 29% of these patients progressing to PsA within 1 year. Significant predictors of progression included a family history of psoriasis (odds ratio [OR], 32; 95% CI, 1.2-1026), synovitis detected by Power Doppler ultrasound (OR, 31; 95% CI, 1.1-967), enthesopathy findings on ultrasound (OR, 75; 95% CI, 13-710), and a low tender joint count (OR, 0.2; 95% CI, 0.05-0.6).
Study details: This prospective longitudinal study included 1419 patients with arthralgia who were older than 18 years of age.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Garcia-Salinas R, Magri S, Mareco J, et al. Arthralgia with risk of progression to psoriatic arthritis: Role of clinical assessments and ultrasound as prognostic factors. Rheumatology (Oxford). Published online October 15, 2024. Source