MDedge Rheumatology

In June, the Concord, Mass.–based company Tremeau Pharmaceuticals announced that the Food and Drug Administration was letting it proceed with a phase 3 clinical trial to test rofecoxib, the once-bestselling painkiller known as Vioxx, in patients with migraine.

The anti-inflammatory drug, a cyclooxygenase-2 (COX-2) inhibitor, received its first FDA approval in 1999 and became widely prescribed for arthritis and acute pain. In 2004 it was withdrawn by its manufacturer, Merck, after being shown to raise the risk of cardiovascular events.

In clinical trials and in real-world epidemiological studies, rofecoxib was associated with elevated heart attack, stroke, and related deaths; one 2005 study estimated that it had been responsible for some 38,000 excess deaths in the United States before being withdrawn. In 2007 Merck, beset with allegations that it had suppressed and mischaracterized rofecoxib’s safety data, paid out nearly $5 billion to settle thousands of lawsuits filed by patients and their families.

Shortly before its withdrawal, rofecoxib was approved for the treatment of migraine. Now, with its original patents expired, Tremeau hopes to gain approval for its reformulated version of the drug in both migraine and in hemophilia arthropathy, an indication for which it received an orphan drug designation in 2017 and the agency’s green light for trials in 2020.

Brad Sippy, Tremeau’s chief executive officer, said that his company chose the two indications in part because both patient populations have low cardiovascular risk. Migraine patients are generally younger than the arthritis populations formerly treated with rofecoxib and are unlikely to take the drug for more than a day or 2 at time, avoiding the risks associated with extended exposure.
 

A crowded market

The past several years have seen the emergence of a cornucopia of new migraine treatments, including monoclonal antibodies such as erenumab (Aimovig, Amgen), which help prevent attacks by blocking the vasodilator calcitonin gene-related peptide, or CGRP. In addition to the standard arsenal of triptans and nonsteroidal anti-inflammatory drugs for acute pain relief, migraine patients can now choose among serotonin-blocking agents such as lasmiditan (Reyvow, Eli Lilly), known as “ditans,” and small-molecule CGRP antagonists such as ubrogepant (Ubrelvy, Abbie), known as “gepants.” Some NSAIDs, including one COX inhibitor, have been formulated into rapidly absorbed powders or liquids for migraine.

Mr. Sippy said he sees a role for rofecoxib even in this crowded space. “Migraine as you know is a multimodal situation – few people say that only one drug works for them,” he said. “We think this is an option that would basically be like a high dose of ibuprofen,” but with less frequent dosing and lower gastrointestinal and platelet effects compared with ibuprofen and other NSAIDs.
 

An improved formulation

Rofecoxib “crosses the blood brain barrier very readily – better than other COX inhibitors on the market,” Mr. Sippy added. “It was well absorbed in its original formulation, and our product is even better absorbed than the original – we estimate it’s probably an hour quicker to [peak concentration].” In addition, he said, “our formulation is more efficient at delivering the drug so we don’t need as much active ingredient – our 17.5 milligrams gets you the same systemic exposure as 25 milligrams of the old product.”

A different mechanism of action

Neurologist Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews and professor of neurology at the University of California, Los Angeles, said that he was “cautiously optimistic” that “if used correctly and not too frequently, [rofecoxib] will find its niche in migraine treatment.”

“Patients liked Vioxx,” said Dr. Rapoport, past president of the International Headache Society. Even people currently on prevention “need to have an acute care drug handy.” While some patients on monoclonal antibodies have had success with gepants for acute care, “these both target the same pathway. It’s always nice to have options with a different mechanism of action.”

One of the arguments Tremeau has cited for reintroducing rofecoxib has been an urgent need for alternatives to opioid painkillers. Indeed some analysts have linked the demise of Vioxx with a subsequent increase in opioid prescribing.

Dr. Rapoport noted that he never prescribes opioids or butalbital, a barbiturate, for migraine, and that most headache specialists avoid them in clinical practice. But in the emergency setting, he said, patients receive them all too frequently.

Mr. Sippy said that opioid prescribing, while not unknown in migraine, was a bigger problem in hemophilic arthropathy, the first indication his company has pursued for rofecoxib. People with hemophilia “have a kind of arthritis that would respond well to an anti-inflammatory drug but they can’t take NSAIDs due to bleeding risk. This is why so many end up on opioids. Rofecoxib, as a COX-2 inhibitor, doesn’t have any effect on platelet aggregation, which would make it another option.”
 

No unique risks at prescribed doses

The migraine indication originally started out narrower: Patients with both migraine and bleeding disorders. “But in talking with the FDA, they encouraged us to develop it for migraine,” Mr. Sippy said. The company is considering pursuing a third indication: menstrual pain co-occurring with migraine. Tremeau has not ruled out seeking an indication in patients with arthritis who cannot take other painkillers, whether opioids or NSAIDs.

Five years ago, when Tremeau first announced its plans to bring rofecoxib back – indeed the company was set up for that purpose and has only this and another COX-2 inhibitor in development – some experts warned that there is little to prevent the drug from being used off-label, whether in higher doses or for other diseases.

“That’s something else we’re seeking to solve in addition to going for younger populations,” said Mr. Sippy, who worked at Merck during the Vioxx crisis and later headed neurology at Sunovion before starting his own company.

“We’re going for the former middle dose as our high dose and now we know that you don’t want to take more than the prescribed amount. If it doesn’t work you get off it; you don’t want to dose-creep on it. That’s been a key insight: At the appropriate dose, this product has no unique risk relative to the drug class and potentially some unique benefits,” he said.
 

Risk versus benefit

Joseph Ross, MD, a health policy researcher at Yale University in New Haven, Conn., who in a 2018 editorial expressed concerns about rofecoxib’s revival, said in an email that he felt its use in migraine could be justified, with caveats.

During Vioxx’s original approval and time on the market, “there was a cardiovascular risk associated with use that was not being transparently and clearly reported to patients and clinicians,” Dr. Ross said.

“In terms of testing the product for use in patients with migraine – a population of generally younger patients at lower risk of cardiovascular disease – my only concern is that the risk is clearly communicated and that there is adequate postmarket safety surveillance,” he said. “If patients are making fully informed decisions, the potential benefit of the drug with respect to pain control may be worth the risks.”

Dr. Rapoport serves as an adviser for AbbVie, Amgen, Biohaven, Cala Health, Collegium Pharmaceutical, Satsuma, Teva, Theranica and Xoc; he is on the speakers bureau of AbbVie, Amgen, Biohaven, Impel, Lundbeck, and Teva. Dr. Ross disclosed research support from Johnson and Johnson, the Medical Device Innovation Consortium, and the Laura and John Arnold Foundation, along with government grants; he is also an expert witness in a lawsuit against Biogen.

In June, the Concord, Mass.–based company Tremeau Pharmaceuticals announced that the Food and Drug Administration was letting it proceed with a phase 3 clinical trial to test rofecoxib, the once-bestselling painkiller known as Vioxx, in patients with migraine.

The anti-inflammatory drug, a cyclooxygenase-2 (COX-2) inhibitor, received its first FDA approval in 1999 and became widely prescribed for arthritis and acute pain. In 2004 it was withdrawn by its manufacturer, Merck, after being shown to raise the risk of cardiovascular events.

In clinical trials and in real-world epidemiological studies, rofecoxib was associated with elevated heart attack, stroke, and related deaths; one 2005 study estimated that it had been responsible for some 38,000 excess deaths in the United States before being withdrawn. In 2007 Merck, beset with allegations that it had suppressed and mischaracterized rofecoxib’s safety data, paid out nearly $5 billion to settle thousands of lawsuits filed by patients and their families.

Shortly before its withdrawal, rofecoxib was approved for the treatment of migraine. Now, with its original patents expired, Tremeau hopes to gain approval for its reformulated version of the drug in both migraine and in hemophilia arthropathy, an indication for which it received an orphan drug designation in 2017 and the agency’s green light for trials in 2020.

Brad Sippy, Tremeau’s chief executive officer, said that his company chose the two indications in part because both patient populations have low cardiovascular risk. Migraine patients are generally younger than the arthritis populations formerly treated with rofecoxib and are unlikely to take the drug for more than a day or 2 at time, avoiding the risks associated with extended exposure.
 

A crowded market

The past several years have seen the emergence of a cornucopia of new migraine treatments, including monoclonal antibodies such as erenumab (Aimovig, Amgen), which help prevent attacks by blocking the vasodilator calcitonin gene-related peptide, or CGRP. In addition to the standard arsenal of triptans and nonsteroidal anti-inflammatory drugs for acute pain relief, migraine patients can now choose among serotonin-blocking agents such as lasmiditan (Reyvow, Eli Lilly), known as “ditans,” and small-molecule CGRP antagonists such as ubrogepant (Ubrelvy, Abbie), known as “gepants.” Some NSAIDs, including one COX inhibitor, have been formulated into rapidly absorbed powders or liquids for migraine.

Mr. Sippy said he sees a role for rofecoxib even in this crowded space. “Migraine as you know is a multimodal situation – few people say that only one drug works for them,” he said. “We think this is an option that would basically be like a high dose of ibuprofen,” but with less frequent dosing and lower gastrointestinal and platelet effects compared with ibuprofen and other NSAIDs.
 

An improved formulation

Rofecoxib “crosses the blood brain barrier very readily – better than other COX inhibitors on the market,” Mr. Sippy added. “It was well absorbed in its original formulation, and our product is even better absorbed than the original – we estimate it’s probably an hour quicker to [peak concentration].” In addition, he said, “our formulation is more efficient at delivering the drug so we don’t need as much active ingredient – our 17.5 milligrams gets you the same systemic exposure as 25 milligrams of the old product.”

A different mechanism of action

Neurologist Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews and professor of neurology at the University of California, Los Angeles, said that he was “cautiously optimistic” that “if used correctly and not too frequently, [rofecoxib] will find its niche in migraine treatment.”

“Patients liked Vioxx,” said Dr. Rapoport, past president of the International Headache Society. Even people currently on prevention “need to have an acute care drug handy.” While some patients on monoclonal antibodies have had success with gepants for acute care, “these both target the same pathway. It’s always nice to have options with a different mechanism of action.”

One of the arguments Tremeau has cited for reintroducing rofecoxib has been an urgent need for alternatives to opioid painkillers. Indeed some analysts have linked the demise of Vioxx with a subsequent increase in opioid prescribing.

Dr. Rapoport noted that he never prescribes opioids or butalbital, a barbiturate, for migraine, and that most headache specialists avoid them in clinical practice. But in the emergency setting, he said, patients receive them all too frequently.

Mr. Sippy said that opioid prescribing, while not unknown in migraine, was a bigger problem in hemophilic arthropathy, the first indication his company has pursued for rofecoxib. People with hemophilia “have a kind of arthritis that would respond well to an anti-inflammatory drug but they can’t take NSAIDs due to bleeding risk. This is why so many end up on opioids. Rofecoxib, as a COX-2 inhibitor, doesn’t have any effect on platelet aggregation, which would make it another option.”
 

No unique risks at prescribed doses

The migraine indication originally started out narrower: Patients with both migraine and bleeding disorders. “But in talking with the FDA, they encouraged us to develop it for migraine,” Mr. Sippy said. The company is considering pursuing a third indication: menstrual pain co-occurring with migraine. Tremeau has not ruled out seeking an indication in patients with arthritis who cannot take other painkillers, whether opioids or NSAIDs.

Five years ago, when Tremeau first announced its plans to bring rofecoxib back – indeed the company was set up for that purpose and has only this and another COX-2 inhibitor in development – some experts warned that there is little to prevent the drug from being used off-label, whether in higher doses or for other diseases.

“That’s something else we’re seeking to solve in addition to going for younger populations,” said Mr. Sippy, who worked at Merck during the Vioxx crisis and later headed neurology at Sunovion before starting his own company.

“We’re going for the former middle dose as our high dose and now we know that you don’t want to take more than the prescribed amount. If it doesn’t work you get off it; you don’t want to dose-creep on it. That’s been a key insight: At the appropriate dose, this product has no unique risk relative to the drug class and potentially some unique benefits,” he said.
 

Risk versus benefit

Joseph Ross, MD, a health policy researcher at Yale University in New Haven, Conn., who in a 2018 editorial expressed concerns about rofecoxib’s revival, said in an email that he felt its use in migraine could be justified, with caveats.

During Vioxx’s original approval and time on the market, “there was a cardiovascular risk associated with use that was not being transparently and clearly reported to patients and clinicians,” Dr. Ross said.

“In terms of testing the product for use in patients with migraine – a population of generally younger patients at lower risk of cardiovascular disease – my only concern is that the risk is clearly communicated and that there is adequate postmarket safety surveillance,” he said. “If patients are making fully informed decisions, the potential benefit of the drug with respect to pain control may be worth the risks.”

Dr. Rapoport serves as an adviser for AbbVie, Amgen, Biohaven, Cala Health, Collegium Pharmaceutical, Satsuma, Teva, Theranica and Xoc; he is on the speakers bureau of AbbVie, Amgen, Biohaven, Impel, Lundbeck, and Teva. Dr. Ross disclosed research support from Johnson and Johnson, the Medical Device Innovation Consortium, and the Laura and John Arnold Foundation, along with government grants; he is also an expert witness in a lawsuit against Biogen.

In June, the Concord, Mass.–based company Tremeau Pharmaceuticals announced that the Food and Drug Administration was letting it proceed with a phase 3 clinical trial to test rofecoxib, the once-bestselling painkiller known as Vioxx, in patients with migraine.

The anti-inflammatory drug, a cyclooxygenase-2 (COX-2) inhibitor, received its first FDA approval in 1999 and became widely prescribed for arthritis and acute pain. In 2004 it was withdrawn by its manufacturer, Merck, after being shown to raise the risk of cardiovascular events.

In clinical trials and in real-world epidemiological studies, rofecoxib was associated with elevated heart attack, stroke, and related deaths; one 2005 study estimated that it had been responsible for some 38,000 excess deaths in the United States before being withdrawn. In 2007 Merck, beset with allegations that it had suppressed and mischaracterized rofecoxib’s safety data, paid out nearly $5 billion to settle thousands of lawsuits filed by patients and their families.

Shortly before its withdrawal, rofecoxib was approved for the treatment of migraine. Now, with its original patents expired, Tremeau hopes to gain approval for its reformulated version of the drug in both migraine and in hemophilia arthropathy, an indication for which it received an orphan drug designation in 2017 and the agency’s green light for trials in 2020.

Brad Sippy, Tremeau’s chief executive officer, said that his company chose the two indications in part because both patient populations have low cardiovascular risk. Migraine patients are generally younger than the arthritis populations formerly treated with rofecoxib and are unlikely to take the drug for more than a day or 2 at time, avoiding the risks associated with extended exposure.
 

A crowded market

The past several years have seen the emergence of a cornucopia of new migraine treatments, including monoclonal antibodies such as erenumab (Aimovig, Amgen), which help prevent attacks by blocking the vasodilator calcitonin gene-related peptide, or CGRP. In addition to the standard arsenal of triptans and nonsteroidal anti-inflammatory drugs for acute pain relief, migraine patients can now choose among serotonin-blocking agents such as lasmiditan (Reyvow, Eli Lilly), known as “ditans,” and small-molecule CGRP antagonists such as ubrogepant (Ubrelvy, Abbie), known as “gepants.” Some NSAIDs, including one COX inhibitor, have been formulated into rapidly absorbed powders or liquids for migraine.

Mr. Sippy said he sees a role for rofecoxib even in this crowded space. “Migraine as you know is a multimodal situation – few people say that only one drug works for them,” he said. “We think this is an option that would basically be like a high dose of ibuprofen,” but with less frequent dosing and lower gastrointestinal and platelet effects compared with ibuprofen and other NSAIDs.
 

An improved formulation

Rofecoxib “crosses the blood brain barrier very readily – better than other COX inhibitors on the market,” Mr. Sippy added. “It was well absorbed in its original formulation, and our product is even better absorbed than the original – we estimate it’s probably an hour quicker to [peak concentration].” In addition, he said, “our formulation is more efficient at delivering the drug so we don’t need as much active ingredient – our 17.5 milligrams gets you the same systemic exposure as 25 milligrams of the old product.”

A different mechanism of action

Neurologist Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews and professor of neurology at the University of California, Los Angeles, said that he was “cautiously optimistic” that “if used correctly and not too frequently, [rofecoxib] will find its niche in migraine treatment.”

“Patients liked Vioxx,” said Dr. Rapoport, past president of the International Headache Society. Even people currently on prevention “need to have an acute care drug handy.” While some patients on monoclonal antibodies have had success with gepants for acute care, “these both target the same pathway. It’s always nice to have options with a different mechanism of action.”

One of the arguments Tremeau has cited for reintroducing rofecoxib has been an urgent need for alternatives to opioid painkillers. Indeed some analysts have linked the demise of Vioxx with a subsequent increase in opioid prescribing.

Dr. Rapoport noted that he never prescribes opioids or butalbital, a barbiturate, for migraine, and that most headache specialists avoid them in clinical practice. But in the emergency setting, he said, patients receive them all too frequently.

Mr. Sippy said that opioid prescribing, while not unknown in migraine, was a bigger problem in hemophilic arthropathy, the first indication his company has pursued for rofecoxib. People with hemophilia “have a kind of arthritis that would respond well to an anti-inflammatory drug but they can’t take NSAIDs due to bleeding risk. This is why so many end up on opioids. Rofecoxib, as a COX-2 inhibitor, doesn’t have any effect on platelet aggregation, which would make it another option.”
 

No unique risks at prescribed doses

The migraine indication originally started out narrower: Patients with both migraine and bleeding disorders. “But in talking with the FDA, they encouraged us to develop it for migraine,” Mr. Sippy said. The company is considering pursuing a third indication: menstrual pain co-occurring with migraine. Tremeau has not ruled out seeking an indication in patients with arthritis who cannot take other painkillers, whether opioids or NSAIDs.

Five years ago, when Tremeau first announced its plans to bring rofecoxib back – indeed the company was set up for that purpose and has only this and another COX-2 inhibitor in development – some experts warned that there is little to prevent the drug from being used off-label, whether in higher doses or for other diseases.

“That’s something else we’re seeking to solve in addition to going for younger populations,” said Mr. Sippy, who worked at Merck during the Vioxx crisis and later headed neurology at Sunovion before starting his own company.

“We’re going for the former middle dose as our high dose and now we know that you don’t want to take more than the prescribed amount. If it doesn’t work you get off it; you don’t want to dose-creep on it. That’s been a key insight: At the appropriate dose, this product has no unique risk relative to the drug class and potentially some unique benefits,” he said.
 

Risk versus benefit

Joseph Ross, MD, a health policy researcher at Yale University in New Haven, Conn., who in a 2018 editorial expressed concerns about rofecoxib’s revival, said in an email that he felt its use in migraine could be justified, with caveats.

During Vioxx’s original approval and time on the market, “there was a cardiovascular risk associated with use that was not being transparently and clearly reported to patients and clinicians,” Dr. Ross said.

“In terms of testing the product for use in patients with migraine – a population of generally younger patients at lower risk of cardiovascular disease – my only concern is that the risk is clearly communicated and that there is adequate postmarket safety surveillance,” he said. “If patients are making fully informed decisions, the potential benefit of the drug with respect to pain control may be worth the risks.”

Dr. Rapoport serves as an adviser for AbbVie, Amgen, Biohaven, Cala Health, Collegium Pharmaceutical, Satsuma, Teva, Theranica and Xoc; he is on the speakers bureau of AbbVie, Amgen, Biohaven, Impel, Lundbeck, and Teva. Dr. Ross disclosed research support from Johnson and Johnson, the Medical Device Innovation Consortium, and the Laura and John Arnold Foundation, along with government grants; he is also an expert witness in a lawsuit against Biogen.

How satisfied are physicians that they are fairly compensated for their dedication, skills, and time? That’s a subject that seems to steer many physicians to heated emotions and to a variety of issues with today’s medical field – not all of which directly affect their pay.

Medscape’s Physician Compensation Report 2022: “Incomes Gain, Pay Gaps Remain” generally shows encouraging trends. Physician income rose from a year earlier, when it stagnated as COVID-19 restrictions led patients to stay home and medical practices to cut hours or close. And for the first time in Medscape’s 11 years of reporting on physician compensation, average income rose for every medical specialty surveyed.

Heartening findings, right? Yet the tone of comments to the report was anything but peppy. Many commenters were highly distressed or even angry about their compensation. One physician even complained his plumber earns more than he does.

A family physician lamented that he has “made less in the past 3 years, with more hassles and work” and he “can’t wait to retire next year.” Meanwhile, he complained, the U.S. health system is “the costliest, yet wasteful, with worse outcomes; reactive, not preventative; and has the costliest drugs and social issues.”
 

Do NPs and PAs encroach on your income?

The conversation about fair compensation launched some commenters into a discussion about competition from nurse practitioners (NPs) and physician assistants (PAs). Some physicians expressed wariness at best, and anger at worst, about NPs and PAs evolving beyond traditional doctor support roles into certain direct patient support.

One-fourth of respondents in the compensation report said their income was negatively affected by competition from NPs, PAs, and other nonphysician providers. For example, with states like Arkansas expanding independent practice for certified registered nurse anesthetists (CRNAs), one commenter complained, “we are no longer needed.”

Added another physician, “primary care, especially internal medicine, is just going away for doctors. We wasted, by all accounts, 4 full years of our working lives because NPs are ‘just as good.’ ”

Greater independence for NPs and PAs strengthens the hands of health insurers and “will end up hastening the demise of primary care as we have known it,” another reader predicted. Other physicians’ takes: “For the institution, it’s much cheaper to hire NPs than to hire doctors” and “overall, physician negotiating power will decrease in the future.”
 

Medicare reimbursement rates grate

Although 7 in 10 respondents in the compensation report said they would continue to accept new Medicare or Medicaid patients, comments reveal resentment about the practical need to work with Medicare and its resentment rates.

“An open question to Medicare: Are you doing the dumbest thing possible by paying low wages and giving huge administrative burdens for internal medicine on purpose?” one physician wrote. “Or are you really that short-sighted?”

Another reader cited an analysis from the American College of Surgeons of Medicare’s 1998 surgical CPT codes. If Medicare had left those codes alone beyond annual inflation adjustments, the study found, reimbursement rates by 2019 would be half of what they became.

Another way of looking at the code reimbursement increases is a 50% pay cut over 20 years for doctors and medical practices, that reader insisted. “The rising cost of employee wages, particularly of the last two-and-a-half years of COVID-19, combined with the effective pay cuts over the last 20 years, equals time to quit!”

Another commenter concurred. “In the 1990s, most full-time docs were making almost double what you see [in the report], and everything cost almost half of what it does now. So, MD purchasing power is between half and one-quarter of what it was in the early 1990s.”
 

Are self-pay models better?

Do physicians have a better chance at consistently fair income under a self-pay practice that avoids dealing with insurance companies?

One commenter hypothesized that psychiatrists once trailed internists in income but today earn more because many “quit working for insurance and went to a cash business 15 years ago.” Many family physicians did something similar by switching to a direct primary care model, he said.

This physician said he has done the same “with great results” for patients as well: shorter office visits, faster booking of appointments, no deductibles owed. Best of all, “I love practicing medicine again, and my patients love the great health care they receive.”

Another commenter agreed. “Two words: cash practice.” But another objected, “I guess only the very rich can afford to cover your business costs.”

Regardless of the payment model, another physician argued for private practice over employed positions. “Save on the bureaucratic expenses. Go back to private practice and get rid of electronic records.”

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

How satisfied are physicians that they are fairly compensated for their dedication, skills, and time? That’s a subject that seems to steer many physicians to heated emotions and to a variety of issues with today’s medical field – not all of which directly affect their pay.

Medscape’s Physician Compensation Report 2022: “Incomes Gain, Pay Gaps Remain” generally shows encouraging trends. Physician income rose from a year earlier, when it stagnated as COVID-19 restrictions led patients to stay home and medical practices to cut hours or close. And for the first time in Medscape’s 11 years of reporting on physician compensation, average income rose for every medical specialty surveyed.

Heartening findings, right? Yet the tone of comments to the report was anything but peppy. Many commenters were highly distressed or even angry about their compensation. One physician even complained his plumber earns more than he does.

A family physician lamented that he has “made less in the past 3 years, with more hassles and work” and he “can’t wait to retire next year.” Meanwhile, he complained, the U.S. health system is “the costliest, yet wasteful, with worse outcomes; reactive, not preventative; and has the costliest drugs and social issues.”
 

Do NPs and PAs encroach on your income?

The conversation about fair compensation launched some commenters into a discussion about competition from nurse practitioners (NPs) and physician assistants (PAs). Some physicians expressed wariness at best, and anger at worst, about NPs and PAs evolving beyond traditional doctor support roles into certain direct patient support.

One-fourth of respondents in the compensation report said their income was negatively affected by competition from NPs, PAs, and other nonphysician providers. For example, with states like Arkansas expanding independent practice for certified registered nurse anesthetists (CRNAs), one commenter complained, “we are no longer needed.”

Added another physician, “primary care, especially internal medicine, is just going away for doctors. We wasted, by all accounts, 4 full years of our working lives because NPs are ‘just as good.’ ”

Greater independence for NPs and PAs strengthens the hands of health insurers and “will end up hastening the demise of primary care as we have known it,” another reader predicted. Other physicians’ takes: “For the institution, it’s much cheaper to hire NPs than to hire doctors” and “overall, physician negotiating power will decrease in the future.”
 

Medicare reimbursement rates grate

Although 7 in 10 respondents in the compensation report said they would continue to accept new Medicare or Medicaid patients, comments reveal resentment about the practical need to work with Medicare and its resentment rates.

“An open question to Medicare: Are you doing the dumbest thing possible by paying low wages and giving huge administrative burdens for internal medicine on purpose?” one physician wrote. “Or are you really that short-sighted?”

Another reader cited an analysis from the American College of Surgeons of Medicare’s 1998 surgical CPT codes. If Medicare had left those codes alone beyond annual inflation adjustments, the study found, reimbursement rates by 2019 would be half of what they became.

Another way of looking at the code reimbursement increases is a 50% pay cut over 20 years for doctors and medical practices, that reader insisted. “The rising cost of employee wages, particularly of the last two-and-a-half years of COVID-19, combined with the effective pay cuts over the last 20 years, equals time to quit!”

Another commenter concurred. “In the 1990s, most full-time docs were making almost double what you see [in the report], and everything cost almost half of what it does now. So, MD purchasing power is between half and one-quarter of what it was in the early 1990s.”
 

Are self-pay models better?

Do physicians have a better chance at consistently fair income under a self-pay practice that avoids dealing with insurance companies?

One commenter hypothesized that psychiatrists once trailed internists in income but today earn more because many “quit working for insurance and went to a cash business 15 years ago.” Many family physicians did something similar by switching to a direct primary care model, he said.

This physician said he has done the same “with great results” for patients as well: shorter office visits, faster booking of appointments, no deductibles owed. Best of all, “I love practicing medicine again, and my patients love the great health care they receive.”

Another commenter agreed. “Two words: cash practice.” But another objected, “I guess only the very rich can afford to cover your business costs.”

Regardless of the payment model, another physician argued for private practice over employed positions. “Save on the bureaucratic expenses. Go back to private practice and get rid of electronic records.”

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

How satisfied are physicians that they are fairly compensated for their dedication, skills, and time? That’s a subject that seems to steer many physicians to heated emotions and to a variety of issues with today’s medical field – not all of which directly affect their pay.

Medscape’s Physician Compensation Report 2022: “Incomes Gain, Pay Gaps Remain” generally shows encouraging trends. Physician income rose from a year earlier, when it stagnated as COVID-19 restrictions led patients to stay home and medical practices to cut hours or close. And for the first time in Medscape’s 11 years of reporting on physician compensation, average income rose for every medical specialty surveyed.

Heartening findings, right? Yet the tone of comments to the report was anything but peppy. Many commenters were highly distressed or even angry about their compensation. One physician even complained his plumber earns more than he does.

A family physician lamented that he has “made less in the past 3 years, with more hassles and work” and he “can’t wait to retire next year.” Meanwhile, he complained, the U.S. health system is “the costliest, yet wasteful, with worse outcomes; reactive, not preventative; and has the costliest drugs and social issues.”
 

Do NPs and PAs encroach on your income?

The conversation about fair compensation launched some commenters into a discussion about competition from nurse practitioners (NPs) and physician assistants (PAs). Some physicians expressed wariness at best, and anger at worst, about NPs and PAs evolving beyond traditional doctor support roles into certain direct patient support.

One-fourth of respondents in the compensation report said their income was negatively affected by competition from NPs, PAs, and other nonphysician providers. For example, with states like Arkansas expanding independent practice for certified registered nurse anesthetists (CRNAs), one commenter complained, “we are no longer needed.”

Added another physician, “primary care, especially internal medicine, is just going away for doctors. We wasted, by all accounts, 4 full years of our working lives because NPs are ‘just as good.’ ”

Greater independence for NPs and PAs strengthens the hands of health insurers and “will end up hastening the demise of primary care as we have known it,” another reader predicted. Other physicians’ takes: “For the institution, it’s much cheaper to hire NPs than to hire doctors” and “overall, physician negotiating power will decrease in the future.”
 

Medicare reimbursement rates grate

Although 7 in 10 respondents in the compensation report said they would continue to accept new Medicare or Medicaid patients, comments reveal resentment about the practical need to work with Medicare and its resentment rates.

“An open question to Medicare: Are you doing the dumbest thing possible by paying low wages and giving huge administrative burdens for internal medicine on purpose?” one physician wrote. “Or are you really that short-sighted?”

Another reader cited an analysis from the American College of Surgeons of Medicare’s 1998 surgical CPT codes. If Medicare had left those codes alone beyond annual inflation adjustments, the study found, reimbursement rates by 2019 would be half of what they became.

Another way of looking at the code reimbursement increases is a 50% pay cut over 20 years for doctors and medical practices, that reader insisted. “The rising cost of employee wages, particularly of the last two-and-a-half years of COVID-19, combined with the effective pay cuts over the last 20 years, equals time to quit!”

Another commenter concurred. “In the 1990s, most full-time docs were making almost double what you see [in the report], and everything cost almost half of what it does now. So, MD purchasing power is between half and one-quarter of what it was in the early 1990s.”
 

Are self-pay models better?

Do physicians have a better chance at consistently fair income under a self-pay practice that avoids dealing with insurance companies?

One commenter hypothesized that psychiatrists once trailed internists in income but today earn more because many “quit working for insurance and went to a cash business 15 years ago.” Many family physicians did something similar by switching to a direct primary care model, he said.

This physician said he has done the same “with great results” for patients as well: shorter office visits, faster booking of appointments, no deductibles owed. Best of all, “I love practicing medicine again, and my patients love the great health care they receive.”

Another commenter agreed. “Two words: cash practice.” But another objected, “I guess only the very rich can afford to cover your business costs.”

Regardless of the payment model, another physician argued for private practice over employed positions. “Save on the bureaucratic expenses. Go back to private practice and get rid of electronic records.”

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

Consumers, employers, and just about everyone else interested in health care prices will soon get an unprecedented look at what insurers pay for care, perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?

As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.

The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.

The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.

“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.

Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.

“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.

Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.

But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

At least at first.

Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.

Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.

With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.

“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.

Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.

The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.

“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”

Other observers are more circumspect.

“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”

Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.

Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.

“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.

That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.

Other employers may bring their insurers back to the bargaining table.

“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.

If that happens, he added, “patients will be able to save money.”

That’s not necessarily a given, however.

Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.

“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.

Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.

Another unknown: Will insurers meet the deadline and provide usable data?

Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.

So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.

Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Consumers, employers, and just about everyone else interested in health care prices will soon get an unprecedented look at what insurers pay for care, perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?

As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.

The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.

The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.

“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.

Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.

“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.

Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.

But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

At least at first.

Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.

Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.

With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.

“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.

Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.

The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.

“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”

Other observers are more circumspect.

“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”

Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.

Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.

“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.

That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.

Other employers may bring their insurers back to the bargaining table.

“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.

If that happens, he added, “patients will be able to save money.”

That’s not necessarily a given, however.

Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.

“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.

Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.

Another unknown: Will insurers meet the deadline and provide usable data?

Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.

So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.

Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Consumers, employers, and just about everyone else interested in health care prices will soon get an unprecedented look at what insurers pay for care, perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?

As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.

The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.

The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.

“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.

Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.

“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.

Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.

But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

At least at first.

Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.

Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.

With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.

“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.

Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.

The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.

“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”

Other observers are more circumspect.

“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”

Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.

Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.

“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.

That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.

Other employers may bring their insurers back to the bargaining table.

“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.

If that happens, he added, “patients will be able to save money.”

That’s not necessarily a given, however.

Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.

“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.

Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.

Another unknown: Will insurers meet the deadline and provide usable data?

Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.

So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.

Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Four risk factors predicted the progression from nonradiographic to radiographic axial spondyloarthritis (axSpA) over a 5-year period in the PROOF study, a global, real-world, prospective, observational study carried out in 29 countries across six different geographic regions.

The predictors of progression within 5 years, based on the presence of radiographic sacroiliitis, included male gender, fulfillment of imaging criteria, HLA-B27 positivity, and a good response to NSAIDs, Denis Poddubnyy, MD, professor of rheumatology at Charité-Universitätsmedizin Berlin, said in his presentation of the study results at the annual European Congress of Rheumatology.

“In this study, 16% of nonradiographic axSpA patients progressed to radiographic axSpA within 5 years, with the mean time to disease progression of 2.4 years,” he said. PROOF (Patients with Axial Spondyloarthritis: Multicountry Registry of Clinical Characteristics) was originally designed to compare demographic and clinical characteristics of patients with axSpA across geographic regions.

In this particular analysis, Dr. Poddubnyy and colleagues aimed to track structural damage progression in the sacroiliac joint over time, as he explained in an interview. The study enrolled 2,633 adults with chronic back pain lasting for at least 3 months with onset before the age of 45 years. This analysis included patients diagnosed with axSpA who also fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA.

Both baseline and follow-up radiographs of sacroiliac joints were evaluated for those with an initial diagnosis of nonradiographic axSpA by two central readers; in cases when the readers disagreed on the classification – either nonradiographic or radiographic axSpA – images were adjudicated by a third reader. Radiographic progression from nonradiographic to radiographic axSpA was evaluated over the next 5 years.

Among all enrolled patients, 82% (n = 2,165) were diagnosed with axSpA and fulfilled the ASAS classification criteria. Of 1,612 who were classified by central reading, 65% had radiographic axSpA while the remaining 35% had nonradiographic axSpA. About 78% of those with nonradiographic axSpA fulfilled the ASAS classification criteria because of positive findings on imaging plus one or more features of spondyloarthritis. The other 22% were classified according to clinical criteria.

A total of 246 nonradiographic axSpA patients who had one or more follow-up radiographs of the sacroiliac joint were included in the current analysis. In this smaller group of patients, progression from the initial diagnosis of nonradiographic to radiographic axSpA at any one point over the 5-year follow-up occurred in 40 patients (16%) at a range of between 0.9 and 5.1 years.

“Females are more likely to stay in the nonradiographic stage than males,” Dr. Poddubnyy noted. Indeed, male gender conferred an over-threefold higher risk of radiographic progression, compared with females (hazard ratio, 3.16; 95% confidence interval, 1.22-8.17; P = .0174). Fulfillment of imaging criteria – in other words, the presence of inflammation on MRI – was also a strong predictor of progression, conferring an over-sixfold risk of radiographic progression (HR, 6.64; 95% CI, 1.37-32.25; P = .0188).

Interestingly, a good response to NSAIDs – the mainstay treatment for both nonradiographic and radiographic axSpA – was also significantly associated with radiographic progression, conferring an over-fourfold risk among those with an initial diagnosis of nonradiographic axSpA (HR, 4.66; 95% CI, 1.23-17.71; P = .0237). And in a separate model, HLA-B27 positivity was significantly associated with radiographic progression, conferring a nearly fourfold higher risk of progression (HR, 3.99; 95% CI, 1.10-14.49; P = .0353).

Asked if rheumatologists need to manage patients with nonradiographic axSpA differently than those with radiographic progression, Dr. Poddubnyy said that there was a small difference between the two in that biologics such as interleukin-17 inhibitors or Janus kinase inhibitors are approved for radiographic axSpA, whereas they are not approved for nonradiographic disease despite some off-label use. “We need to have high levels of symptoms plus nonresponse to NSAIDs and then we can prescribe a biologic,” he added.

For patients with nonradiographic axSpA, patients similarly need to have a high symptom burden and a nonresponse to NSAIDs, but in addition, physicians need to demonstrate objective signs of inflammatory activity, such as an elevated C-reactive protein level or the presence of inflammation on MRI before moving on the next level.

AbbVie funded the PROOF study. Dr. Poddubnyy declared receiving speaker bureau fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, and UCB. He has also served as a consultant for AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Samsung Bioepis, and UCB, as well as research support from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Pfizer. A number of coauthors also disclosed financial relationships with these and other pharmaceutical companies.

Four risk factors predicted the progression from nonradiographic to radiographic axial spondyloarthritis (axSpA) over a 5-year period in the PROOF study, a global, real-world, prospective, observational study carried out in 29 countries across six different geographic regions.

The predictors of progression within 5 years, based on the presence of radiographic sacroiliitis, included male gender, fulfillment of imaging criteria, HLA-B27 positivity, and a good response to NSAIDs, Denis Poddubnyy, MD, professor of rheumatology at Charité-Universitätsmedizin Berlin, said in his presentation of the study results at the annual European Congress of Rheumatology.

“In this study, 16% of nonradiographic axSpA patients progressed to radiographic axSpA within 5 years, with the mean time to disease progression of 2.4 years,” he said. PROOF (Patients with Axial Spondyloarthritis: Multicountry Registry of Clinical Characteristics) was originally designed to compare demographic and clinical characteristics of patients with axSpA across geographic regions.

In this particular analysis, Dr. Poddubnyy and colleagues aimed to track structural damage progression in the sacroiliac joint over time, as he explained in an interview. The study enrolled 2,633 adults with chronic back pain lasting for at least 3 months with onset before the age of 45 years. This analysis included patients diagnosed with axSpA who also fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA.

Both baseline and follow-up radiographs of sacroiliac joints were evaluated for those with an initial diagnosis of nonradiographic axSpA by two central readers; in cases when the readers disagreed on the classification – either nonradiographic or radiographic axSpA – images were adjudicated by a third reader. Radiographic progression from nonradiographic to radiographic axSpA was evaluated over the next 5 years.

Among all enrolled patients, 82% (n = 2,165) were diagnosed with axSpA and fulfilled the ASAS classification criteria. Of 1,612 who were classified by central reading, 65% had radiographic axSpA while the remaining 35% had nonradiographic axSpA. About 78% of those with nonradiographic axSpA fulfilled the ASAS classification criteria because of positive findings on imaging plus one or more features of spondyloarthritis. The other 22% were classified according to clinical criteria.

A total of 246 nonradiographic axSpA patients who had one or more follow-up radiographs of the sacroiliac joint were included in the current analysis. In this smaller group of patients, progression from the initial diagnosis of nonradiographic to radiographic axSpA at any one point over the 5-year follow-up occurred in 40 patients (16%) at a range of between 0.9 and 5.1 years.

“Females are more likely to stay in the nonradiographic stage than males,” Dr. Poddubnyy noted. Indeed, male gender conferred an over-threefold higher risk of radiographic progression, compared with females (hazard ratio, 3.16; 95% confidence interval, 1.22-8.17; P = .0174). Fulfillment of imaging criteria – in other words, the presence of inflammation on MRI – was also a strong predictor of progression, conferring an over-sixfold risk of radiographic progression (HR, 6.64; 95% CI, 1.37-32.25; P = .0188).

Interestingly, a good response to NSAIDs – the mainstay treatment for both nonradiographic and radiographic axSpA – was also significantly associated with radiographic progression, conferring an over-fourfold risk among those with an initial diagnosis of nonradiographic axSpA (HR, 4.66; 95% CI, 1.23-17.71; P = .0237). And in a separate model, HLA-B27 positivity was significantly associated with radiographic progression, conferring a nearly fourfold higher risk of progression (HR, 3.99; 95% CI, 1.10-14.49; P = .0353).

Asked if rheumatologists need to manage patients with nonradiographic axSpA differently than those with radiographic progression, Dr. Poddubnyy said that there was a small difference between the two in that biologics such as interleukin-17 inhibitors or Janus kinase inhibitors are approved for radiographic axSpA, whereas they are not approved for nonradiographic disease despite some off-label use. “We need to have high levels of symptoms plus nonresponse to NSAIDs and then we can prescribe a biologic,” he added.

For patients with nonradiographic axSpA, patients similarly need to have a high symptom burden and a nonresponse to NSAIDs, but in addition, physicians need to demonstrate objective signs of inflammatory activity, such as an elevated C-reactive protein level or the presence of inflammation on MRI before moving on the next level.

AbbVie funded the PROOF study. Dr. Poddubnyy declared receiving speaker bureau fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, and UCB. He has also served as a consultant for AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Samsung Bioepis, and UCB, as well as research support from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Pfizer. A number of coauthors also disclosed financial relationships with these and other pharmaceutical companies.

Four risk factors predicted the progression from nonradiographic to radiographic axial spondyloarthritis (axSpA) over a 5-year period in the PROOF study, a global, real-world, prospective, observational study carried out in 29 countries across six different geographic regions.

The predictors of progression within 5 years, based on the presence of radiographic sacroiliitis, included male gender, fulfillment of imaging criteria, HLA-B27 positivity, and a good response to NSAIDs, Denis Poddubnyy, MD, professor of rheumatology at Charité-Universitätsmedizin Berlin, said in his presentation of the study results at the annual European Congress of Rheumatology.

“In this study, 16% of nonradiographic axSpA patients progressed to radiographic axSpA within 5 years, with the mean time to disease progression of 2.4 years,” he said. PROOF (Patients with Axial Spondyloarthritis: Multicountry Registry of Clinical Characteristics) was originally designed to compare demographic and clinical characteristics of patients with axSpA across geographic regions.

In this particular analysis, Dr. Poddubnyy and colleagues aimed to track structural damage progression in the sacroiliac joint over time, as he explained in an interview. The study enrolled 2,633 adults with chronic back pain lasting for at least 3 months with onset before the age of 45 years. This analysis included patients diagnosed with axSpA who also fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA.

Both baseline and follow-up radiographs of sacroiliac joints were evaluated for those with an initial diagnosis of nonradiographic axSpA by two central readers; in cases when the readers disagreed on the classification – either nonradiographic or radiographic axSpA – images were adjudicated by a third reader. Radiographic progression from nonradiographic to radiographic axSpA was evaluated over the next 5 years.

Among all enrolled patients, 82% (n = 2,165) were diagnosed with axSpA and fulfilled the ASAS classification criteria. Of 1,612 who were classified by central reading, 65% had radiographic axSpA while the remaining 35% had nonradiographic axSpA. About 78% of those with nonradiographic axSpA fulfilled the ASAS classification criteria because of positive findings on imaging plus one or more features of spondyloarthritis. The other 22% were classified according to clinical criteria.

A total of 246 nonradiographic axSpA patients who had one or more follow-up radiographs of the sacroiliac joint were included in the current analysis. In this smaller group of patients, progression from the initial diagnosis of nonradiographic to radiographic axSpA at any one point over the 5-year follow-up occurred in 40 patients (16%) at a range of between 0.9 and 5.1 years.

“Females are more likely to stay in the nonradiographic stage than males,” Dr. Poddubnyy noted. Indeed, male gender conferred an over-threefold higher risk of radiographic progression, compared with females (hazard ratio, 3.16; 95% confidence interval, 1.22-8.17; P = .0174). Fulfillment of imaging criteria – in other words, the presence of inflammation on MRI – was also a strong predictor of progression, conferring an over-sixfold risk of radiographic progression (HR, 6.64; 95% CI, 1.37-32.25; P = .0188).

Interestingly, a good response to NSAIDs – the mainstay treatment for both nonradiographic and radiographic axSpA – was also significantly associated with radiographic progression, conferring an over-fourfold risk among those with an initial diagnosis of nonradiographic axSpA (HR, 4.66; 95% CI, 1.23-17.71; P = .0237). And in a separate model, HLA-B27 positivity was significantly associated with radiographic progression, conferring a nearly fourfold higher risk of progression (HR, 3.99; 95% CI, 1.10-14.49; P = .0353).

Asked if rheumatologists need to manage patients with nonradiographic axSpA differently than those with radiographic progression, Dr. Poddubnyy said that there was a small difference between the two in that biologics such as interleukin-17 inhibitors or Janus kinase inhibitors are approved for radiographic axSpA, whereas they are not approved for nonradiographic disease despite some off-label use. “We need to have high levels of symptoms plus nonresponse to NSAIDs and then we can prescribe a biologic,” he added.

For patients with nonradiographic axSpA, patients similarly need to have a high symptom burden and a nonresponse to NSAIDs, but in addition, physicians need to demonstrate objective signs of inflammatory activity, such as an elevated C-reactive protein level or the presence of inflammation on MRI before moving on the next level.

AbbVie funded the PROOF study. Dr. Poddubnyy declared receiving speaker bureau fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, and UCB. He has also served as a consultant for AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Samsung Bioepis, and UCB, as well as research support from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Pfizer. A number of coauthors also disclosed financial relationships with these and other pharmaceutical companies.

Acute exacerbations (AEs) are both common in rheumatoid arthritis–associated interstitial lung disease (RA-ILD) and are a frequent cause of imminent mortality, a retrospective Japanese study suggests.

The same is also true for patients with idiopathic pulmonary fibrosis (IPF) for whom an AE is the most frequent cause of death as well, the same comparative study indicates.

“Several studies have reported that acute exacerbation, which occurs during the clinical course of idiopathic pulmonary fibrosis (IPF), also occurs in rheumatoid arthritis–associated interstitial lung disease (RA-ILD),” lead author Junji Otsuka, MD, PhD, of the National Hospital Organization Omuta National Hospital, Fukuoka, Japan, and colleagues observed.

“[We found that] AE was not uncommon in RA-ILD or IPF ... but the prognosis after AE of RA-ILD was significantly better than that of IPF [even though] the most frequent cause of death in RA-ILD and IPF was AE,” they stated.

The study was published online in Respiratory Medicine.

Patient features

The study involved 149 RA-ILD patients with a median age of 72 years at RA onset. The median time from ILD diagnosis to onset of AE was 48.5 months, while the median survival time after the onset of AE was 196 days (range 1-3,463 days), as the authors detailed. “All patients were treated with corticosteroids,” the authors noted, and almost all of them were treated with steroid pulse therapy.

Noninvasive positive pressure ventilation (NPPV) was used to maintain oxygenation in 18.5% of patients with severe respiratory failure, while invasive positive pressure ventilation (IPPV) was used in almost 26% of patients with the same degree of respiratory failure. Features of patients who developed an AE were then compared with those who did not.

Interestingly, no significant differences in clinical parameters were seen between those who developed an AE and those who did not. Nor were there any significant differences between the 2 groups in the length of time from the ILD diagnosis to the development of an AE. Some 18% of RA-ILD patients developed an AE, as did over 27% of patients with IPF, investigators report.

The median survival after RA-ILD patients developed an AE was 277 days, compared with only 60 days for those with IPF (P = .038). In a multivariable analysis, hypoalbuminemia at an odds ratio of .090 (95% confidence interval, 0.011-0.733; P = .012) as well as percent carbon monoxide diffusion capacity at an OR of .810 (95% CI, 0.814-0.964; P < .01) were both independent risk factors for the development of an AE, the investigators pointed out.

The best cut-off level for predicting the risk of an AE was 3.0 g/dL (95% CI, 0.011-0.733; P = .012) for serum albumin and 53% (95% CI, 0.814-0.964; P < .01) for carbon monoxide diffusion capacity. As Dr. Otsuka noted in an email to this news organization, low serum albumin likely correlates with a generally poor condition, while low carbon monoxide diffusion capacity is likely due to lung fibrosis.

“But if low albumin and low carbon monoxide diffusion capacity are due to the progression of ILD, both values may be difficult to improve,” he added.
 

Survivors versus nonsurvivors

Of those patients with RA-ILD who developed an AE, approximately half recovered. Among the IPF patients who developed an AE during the study period, approximately 39% recovered from the event, while 70% did not. Comparing RA-ILD patients who survived versus whose who did not, again, no significant demographic or clinical differences were seen between the 2 groups. On the other hand, the number of patients treated with immunosuppressants for their AE was significantly higher among patients who did not survive the AE, compared with those who did (P =.022), investigators note.

Similarly, the number of patients who required NPPV was also significantly higher among those who did not survive, compared with those who did. In fact, “none of the surviving patients used NPPV (P <0.01),” the authors stress. The number of patients who required IPPV was also significantly higher among nonsurvivors than among survivors (P =.017), and of the small number of patients who were treated with IPPV, all but one died without recovery.

As the authors suggested, these findings suggest that RA-ILD patients who recover from an AE with the help of corticosteroids alone have a relatively decent prognosis. In contrast, those who require immunosuppressive drugs in addition to steroids or mechanical ventilation for AE management can be expected to have a poor prognosis.

The same can also be said for IPF patients and even with the help of mechanical ventilation “with IPF patients, the survival rate is low anyway, so the indication for mechanical ventilation should be carefully judged,” Dr. Otsuka stressed.
 

Cause of death

The authors also compared the cause of death between patients with RA-ILD and those with IPF. “In RA-ILD patients, the most frequent cause of death was AE,” they report, at close to 35% of all patients with RA-ILD. This was also true for IPF patients among whom AE was the cause of death for over 44%. “These results indicate that, as in IPF, AE develops in the clinical course of RA-ILD with considerable frequency,” investigators note.

“During the clinical course of RA-ILD, as with IPD, it is necessary to pay attention to AE,” they stress. Dr. Otsuka added: “It may be difficult to change the prognosis of these patients.”

“However, knowing which patients are more likely to develop AE may help predict the prognosis, and it may be improved if antifibrotic agents are used for these patients,” he said. Elizabeth Volkmann, MD, director, UCLA scleroderma program, University of California, Los Angeles, felt that understanding the risk factors for AEs in this patient population may help physicians identify a subgroup of patients with RA-ILD who require closer monitoring and follow-up.

“These patients may also require more aggressive treatment for RA-ILD to prevent AEs,” she said in an email to this news organization. Given that the study was retrospective in nature, Dr. Volkmann cautioned that there were likely multiple confounding factors that could have affected survival in this patient population and not to take away from the study that survival was solely affected by immunosuppressant use, for example.

“It is possible that patients [treated with] immunosuppressants had other features of their disease that independently heightened their risk of mortality,” Dr. Volkmann said. Similarly, physicians should not assume that the high mortality rate seen in RA-ILD patients who were treated with mechanical ventilation had anything to do with mechanical ventilation itself, as patients requiring ventilation are likely to have worse outcomes, as she stressed.

As for hypoalbuminemia, Dr. Volkmann pointed out that hypoalbuminemia is often a sign of malnutrition in these patients. “Studies have demonstrated that malnutrition is an independent predictor of mortality in patients with ILD,” she emphasized.

“Optimizing patients’ nutritional status could potentially help lower the risk of AEs,” Dr. Volkmann suggested.

Limitations of the study include the fact that it was a single-center design study and included only a limited number of patients.

No specific funding source was noted. The authors have no conflicts of interest to declare.

Acute exacerbations (AEs) are both common in rheumatoid arthritis–associated interstitial lung disease (RA-ILD) and are a frequent cause of imminent mortality, a retrospective Japanese study suggests.

The same is also true for patients with idiopathic pulmonary fibrosis (IPF) for whom an AE is the most frequent cause of death as well, the same comparative study indicates.

“Several studies have reported that acute exacerbation, which occurs during the clinical course of idiopathic pulmonary fibrosis (IPF), also occurs in rheumatoid arthritis–associated interstitial lung disease (RA-ILD),” lead author Junji Otsuka, MD, PhD, of the National Hospital Organization Omuta National Hospital, Fukuoka, Japan, and colleagues observed.

“[We found that] AE was not uncommon in RA-ILD or IPF ... but the prognosis after AE of RA-ILD was significantly better than that of IPF [even though] the most frequent cause of death in RA-ILD and IPF was AE,” they stated.

The study was published online in Respiratory Medicine.

Patient features

The study involved 149 RA-ILD patients with a median age of 72 years at RA onset. The median time from ILD diagnosis to onset of AE was 48.5 months, while the median survival time after the onset of AE was 196 days (range 1-3,463 days), as the authors detailed. “All patients were treated with corticosteroids,” the authors noted, and almost all of them were treated with steroid pulse therapy.

Noninvasive positive pressure ventilation (NPPV) was used to maintain oxygenation in 18.5% of patients with severe respiratory failure, while invasive positive pressure ventilation (IPPV) was used in almost 26% of patients with the same degree of respiratory failure. Features of patients who developed an AE were then compared with those who did not.

Interestingly, no significant differences in clinical parameters were seen between those who developed an AE and those who did not. Nor were there any significant differences between the 2 groups in the length of time from the ILD diagnosis to the development of an AE. Some 18% of RA-ILD patients developed an AE, as did over 27% of patients with IPF, investigators report.

The median survival after RA-ILD patients developed an AE was 277 days, compared with only 60 days for those with IPF (P = .038). In a multivariable analysis, hypoalbuminemia at an odds ratio of .090 (95% confidence interval, 0.011-0.733; P = .012) as well as percent carbon monoxide diffusion capacity at an OR of .810 (95% CI, 0.814-0.964; P < .01) were both independent risk factors for the development of an AE, the investigators pointed out.

The best cut-off level for predicting the risk of an AE was 3.0 g/dL (95% CI, 0.011-0.733; P = .012) for serum albumin and 53% (95% CI, 0.814-0.964; P < .01) for carbon monoxide diffusion capacity. As Dr. Otsuka noted in an email to this news organization, low serum albumin likely correlates with a generally poor condition, while low carbon monoxide diffusion capacity is likely due to lung fibrosis.

“But if low albumin and low carbon monoxide diffusion capacity are due to the progression of ILD, both values may be difficult to improve,” he added.
 

Survivors versus nonsurvivors

Of those patients with RA-ILD who developed an AE, approximately half recovered. Among the IPF patients who developed an AE during the study period, approximately 39% recovered from the event, while 70% did not. Comparing RA-ILD patients who survived versus whose who did not, again, no significant demographic or clinical differences were seen between the 2 groups. On the other hand, the number of patients treated with immunosuppressants for their AE was significantly higher among patients who did not survive the AE, compared with those who did (P =.022), investigators note.

Similarly, the number of patients who required NPPV was also significantly higher among those who did not survive, compared with those who did. In fact, “none of the surviving patients used NPPV (P <0.01),” the authors stress. The number of patients who required IPPV was also significantly higher among nonsurvivors than among survivors (P =.017), and of the small number of patients who were treated with IPPV, all but one died without recovery.

As the authors suggested, these findings suggest that RA-ILD patients who recover from an AE with the help of corticosteroids alone have a relatively decent prognosis. In contrast, those who require immunosuppressive drugs in addition to steroids or mechanical ventilation for AE management can be expected to have a poor prognosis.

The same can also be said for IPF patients and even with the help of mechanical ventilation “with IPF patients, the survival rate is low anyway, so the indication for mechanical ventilation should be carefully judged,” Dr. Otsuka stressed.
 

Cause of death

The authors also compared the cause of death between patients with RA-ILD and those with IPF. “In RA-ILD patients, the most frequent cause of death was AE,” they report, at close to 35% of all patients with RA-ILD. This was also true for IPF patients among whom AE was the cause of death for over 44%. “These results indicate that, as in IPF, AE develops in the clinical course of RA-ILD with considerable frequency,” investigators note.

“During the clinical course of RA-ILD, as with IPD, it is necessary to pay attention to AE,” they stress. Dr. Otsuka added: “It may be difficult to change the prognosis of these patients.”

“However, knowing which patients are more likely to develop AE may help predict the prognosis, and it may be improved if antifibrotic agents are used for these patients,” he said. Elizabeth Volkmann, MD, director, UCLA scleroderma program, University of California, Los Angeles, felt that understanding the risk factors for AEs in this patient population may help physicians identify a subgroup of patients with RA-ILD who require closer monitoring and follow-up.

“These patients may also require more aggressive treatment for RA-ILD to prevent AEs,” she said in an email to this news organization. Given that the study was retrospective in nature, Dr. Volkmann cautioned that there were likely multiple confounding factors that could have affected survival in this patient population and not to take away from the study that survival was solely affected by immunosuppressant use, for example.

“It is possible that patients [treated with] immunosuppressants had other features of their disease that independently heightened their risk of mortality,” Dr. Volkmann said. Similarly, physicians should not assume that the high mortality rate seen in RA-ILD patients who were treated with mechanical ventilation had anything to do with mechanical ventilation itself, as patients requiring ventilation are likely to have worse outcomes, as she stressed.

As for hypoalbuminemia, Dr. Volkmann pointed out that hypoalbuminemia is often a sign of malnutrition in these patients. “Studies have demonstrated that malnutrition is an independent predictor of mortality in patients with ILD,” she emphasized.

“Optimizing patients’ nutritional status could potentially help lower the risk of AEs,” Dr. Volkmann suggested.

Limitations of the study include the fact that it was a single-center design study and included only a limited number of patients.

No specific funding source was noted. The authors have no conflicts of interest to declare.

Acute exacerbations (AEs) are both common in rheumatoid arthritis–associated interstitial lung disease (RA-ILD) and are a frequent cause of imminent mortality, a retrospective Japanese study suggests.

The same is also true for patients with idiopathic pulmonary fibrosis (IPF) for whom an AE is the most frequent cause of death as well, the same comparative study indicates.

“Several studies have reported that acute exacerbation, which occurs during the clinical course of idiopathic pulmonary fibrosis (IPF), also occurs in rheumatoid arthritis–associated interstitial lung disease (RA-ILD),” lead author Junji Otsuka, MD, PhD, of the National Hospital Organization Omuta National Hospital, Fukuoka, Japan, and colleagues observed.

“[We found that] AE was not uncommon in RA-ILD or IPF ... but the prognosis after AE of RA-ILD was significantly better than that of IPF [even though] the most frequent cause of death in RA-ILD and IPF was AE,” they stated.

The study was published online in Respiratory Medicine.

Patient features

The study involved 149 RA-ILD patients with a median age of 72 years at RA onset. The median time from ILD diagnosis to onset of AE was 48.5 months, while the median survival time after the onset of AE was 196 days (range 1-3,463 days), as the authors detailed. “All patients were treated with corticosteroids,” the authors noted, and almost all of them were treated with steroid pulse therapy.

Noninvasive positive pressure ventilation (NPPV) was used to maintain oxygenation in 18.5% of patients with severe respiratory failure, while invasive positive pressure ventilation (IPPV) was used in almost 26% of patients with the same degree of respiratory failure. Features of patients who developed an AE were then compared with those who did not.

Interestingly, no significant differences in clinical parameters were seen between those who developed an AE and those who did not. Nor were there any significant differences between the 2 groups in the length of time from the ILD diagnosis to the development of an AE. Some 18% of RA-ILD patients developed an AE, as did over 27% of patients with IPF, investigators report.

The median survival after RA-ILD patients developed an AE was 277 days, compared with only 60 days for those with IPF (P = .038). In a multivariable analysis, hypoalbuminemia at an odds ratio of .090 (95% confidence interval, 0.011-0.733; P = .012) as well as percent carbon monoxide diffusion capacity at an OR of .810 (95% CI, 0.814-0.964; P < .01) were both independent risk factors for the development of an AE, the investigators pointed out.

The best cut-off level for predicting the risk of an AE was 3.0 g/dL (95% CI, 0.011-0.733; P = .012) for serum albumin and 53% (95% CI, 0.814-0.964; P < .01) for carbon monoxide diffusion capacity. As Dr. Otsuka noted in an email to this news organization, low serum albumin likely correlates with a generally poor condition, while low carbon monoxide diffusion capacity is likely due to lung fibrosis.

“But if low albumin and low carbon monoxide diffusion capacity are due to the progression of ILD, both values may be difficult to improve,” he added.
 

Survivors versus nonsurvivors

Of those patients with RA-ILD who developed an AE, approximately half recovered. Among the IPF patients who developed an AE during the study period, approximately 39% recovered from the event, while 70% did not. Comparing RA-ILD patients who survived versus whose who did not, again, no significant demographic or clinical differences were seen between the 2 groups. On the other hand, the number of patients treated with immunosuppressants for their AE was significantly higher among patients who did not survive the AE, compared with those who did (P =.022), investigators note.

Similarly, the number of patients who required NPPV was also significantly higher among those who did not survive, compared with those who did. In fact, “none of the surviving patients used NPPV (P <0.01),” the authors stress. The number of patients who required IPPV was also significantly higher among nonsurvivors than among survivors (P =.017), and of the small number of patients who were treated with IPPV, all but one died without recovery.

As the authors suggested, these findings suggest that RA-ILD patients who recover from an AE with the help of corticosteroids alone have a relatively decent prognosis. In contrast, those who require immunosuppressive drugs in addition to steroids or mechanical ventilation for AE management can be expected to have a poor prognosis.

The same can also be said for IPF patients and even with the help of mechanical ventilation “with IPF patients, the survival rate is low anyway, so the indication for mechanical ventilation should be carefully judged,” Dr. Otsuka stressed.
 

Cause of death

The authors also compared the cause of death between patients with RA-ILD and those with IPF. “In RA-ILD patients, the most frequent cause of death was AE,” they report, at close to 35% of all patients with RA-ILD. This was also true for IPF patients among whom AE was the cause of death for over 44%. “These results indicate that, as in IPF, AE develops in the clinical course of RA-ILD with considerable frequency,” investigators note.

“During the clinical course of RA-ILD, as with IPD, it is necessary to pay attention to AE,” they stress. Dr. Otsuka added: “It may be difficult to change the prognosis of these patients.”

“However, knowing which patients are more likely to develop AE may help predict the prognosis, and it may be improved if antifibrotic agents are used for these patients,” he said. Elizabeth Volkmann, MD, director, UCLA scleroderma program, University of California, Los Angeles, felt that understanding the risk factors for AEs in this patient population may help physicians identify a subgroup of patients with RA-ILD who require closer monitoring and follow-up.

“These patients may also require more aggressive treatment for RA-ILD to prevent AEs,” she said in an email to this news organization. Given that the study was retrospective in nature, Dr. Volkmann cautioned that there were likely multiple confounding factors that could have affected survival in this patient population and not to take away from the study that survival was solely affected by immunosuppressant use, for example.

“It is possible that patients [treated with] immunosuppressants had other features of their disease that independently heightened their risk of mortality,” Dr. Volkmann said. Similarly, physicians should not assume that the high mortality rate seen in RA-ILD patients who were treated with mechanical ventilation had anything to do with mechanical ventilation itself, as patients requiring ventilation are likely to have worse outcomes, as she stressed.

As for hypoalbuminemia, Dr. Volkmann pointed out that hypoalbuminemia is often a sign of malnutrition in these patients. “Studies have demonstrated that malnutrition is an independent predictor of mortality in patients with ILD,” she emphasized.

“Optimizing patients’ nutritional status could potentially help lower the risk of AEs,” Dr. Volkmann suggested.

Limitations of the study include the fact that it was a single-center design study and included only a limited number of patients.

No specific funding source was noted. The authors have no conflicts of interest to declare.

In keeping with other studies suggesting that lower-than-standard doses of rituximab (for example, two 500 mg doses every 6 months) are effective in the treatment of rheumatoid arthritis (RA), Bertsias and colleagues evaluated the efficacy of low-dose rituximab (1 g every 6 months) in a cohort of patients with RA. Of 361 patients in the initial registry, 81 achieved sustained low disease activity or remission on standard rituximab regimens and were transitioned to the low-dose regimen; their outcomes were compared with the 280 patients in the registry who received a standard-dose regimen. Only 7.5% experienced flares of RA (compared with 5.9% in the standard-dose group), and patients in the low-dose group had fewer serious adverse events, infections, and hospitalizations. Tapering biologic disease-modifying antirheumatic drugs (DMARD) may thus be a reasonable strategy for some patients with RA, with an eye to their prior results with the medication.

The prospect of achieving sustained DMARD-free remission (SDFR) in people with RA has seemed increasingly feasible in recent studies, although it seems to be affected by anti-citrullinated protein/peptide antibody (ACPA) positivity. That is, people who are ACPA-negative are more likely to reach this target. Verstappen and colleagues examined MRI patterns of joint inflammation in the Leiden Early Arthritis Clinic cohort, as well as another cohort of patients with RA, but only included patients with an RA duration > 1 year to reduce the likelihood of misclassification. Interestingly, ACPA-positive patients who achieved SDFR tended to have lower baseline evidence of joint inflammation (including erosions, synovitis, and osteitis), which was persistent throughout follow-up, whereas ACPA-negative patients who achieved SDFR had similar joint inflammation at baseline to those who did not, but had a better initial response to DMARD therapy. Further study of the potential impact of treatment based on ACPA status would be helpful.

Recent results from the ORAL Surveillance postmarketing safety analysis suggest that tofacitinib is associated with an increased risk for cancer in patients with RA patients who are aged >50 years, compared with anti–tumor necrosis factor (TNF) agents. Khosrow-Khavar and colleagues used insurance claims data to further investigate the risk for cancer with tofacitinib vs anti-TNF agents. They created two cohorts of patients who were new users of anti-TNF agents or tofacitinib: One was a "real-world" cohort including all patients with RA, whereas the other applied the inclusion and exclusion criteria from the ORAL Surveillance trial, including age >50 years, one cardiovascular risk factor, and use of methotrexate. Results from the real-world cohort, including over 10,000 patients who had used tofacitinib, did not show any increase in cancer risk, whereas the trial-simulating conditions did yield higher numbers of cancers in the group exposed to tofacitinib. Though reassuring, these results are limited by the short follow-up duration, and longer-term follow-up studies are necessary for further evaluation.

In another interesting note with respect to medication morbidity and risk, Xu and colleagues performed a meta-analysis looking at the association of methotrexate use and mortality in patients with RA. Only 15 studies were included in the final analysis, though they did encompass a large total number of patients. Overall, methotrexate use in these studies was associated with lower rates of overall mortality as well as mortality due to cardiovascular and interstitial lung disease. However, conclusions as to the direct impact of methotrexate were limited by the heterogeneity of study designs, doses of methotrexate, and additional therapy as well as comparators.

In keeping with other studies suggesting that lower-than-standard doses of rituximab (for example, two 500 mg doses every 6 months) are effective in the treatment of rheumatoid arthritis (RA), Bertsias and colleagues evaluated the efficacy of low-dose rituximab (1 g every 6 months) in a cohort of patients with RA. Of 361 patients in the initial registry, 81 achieved sustained low disease activity or remission on standard rituximab regimens and were transitioned to the low-dose regimen; their outcomes were compared with the 280 patients in the registry who received a standard-dose regimen. Only 7.5% experienced flares of RA (compared with 5.9% in the standard-dose group), and patients in the low-dose group had fewer serious adverse events, infections, and hospitalizations. Tapering biologic disease-modifying antirheumatic drugs (DMARD) may thus be a reasonable strategy for some patients with RA, with an eye to their prior results with the medication.

The prospect of achieving sustained DMARD-free remission (SDFR) in people with RA has seemed increasingly feasible in recent studies, although it seems to be affected by anti-citrullinated protein/peptide antibody (ACPA) positivity. That is, people who are ACPA-negative are more likely to reach this target. Verstappen and colleagues examined MRI patterns of joint inflammation in the Leiden Early Arthritis Clinic cohort, as well as another cohort of patients with RA, but only included patients with an RA duration > 1 year to reduce the likelihood of misclassification. Interestingly, ACPA-positive patients who achieved SDFR tended to have lower baseline evidence of joint inflammation (including erosions, synovitis, and osteitis), which was persistent throughout follow-up, whereas ACPA-negative patients who achieved SDFR had similar joint inflammation at baseline to those who did not, but had a better initial response to DMARD therapy. Further study of the potential impact of treatment based on ACPA status would be helpful.

Recent results from the ORAL Surveillance postmarketing safety analysis suggest that tofacitinib is associated with an increased risk for cancer in patients with RA patients who are aged >50 years, compared with anti–tumor necrosis factor (TNF) agents. Khosrow-Khavar and colleagues used insurance claims data to further investigate the risk for cancer with tofacitinib vs anti-TNF agents. They created two cohorts of patients who were new users of anti-TNF agents or tofacitinib: One was a "real-world" cohort including all patients with RA, whereas the other applied the inclusion and exclusion criteria from the ORAL Surveillance trial, including age >50 years, one cardiovascular risk factor, and use of methotrexate. Results from the real-world cohort, including over 10,000 patients who had used tofacitinib, did not show any increase in cancer risk, whereas the trial-simulating conditions did yield higher numbers of cancers in the group exposed to tofacitinib. Though reassuring, these results are limited by the short follow-up duration, and longer-term follow-up studies are necessary for further evaluation.

In another interesting note with respect to medication morbidity and risk, Xu and colleagues performed a meta-analysis looking at the association of methotrexate use and mortality in patients with RA. Only 15 studies were included in the final analysis, though they did encompass a large total number of patients. Overall, methotrexate use in these studies was associated with lower rates of overall mortality as well as mortality due to cardiovascular and interstitial lung disease. However, conclusions as to the direct impact of methotrexate were limited by the heterogeneity of study designs, doses of methotrexate, and additional therapy as well as comparators.

In keeping with other studies suggesting that lower-than-standard doses of rituximab (for example, two 500 mg doses every 6 months) are effective in the treatment of rheumatoid arthritis (RA), Bertsias and colleagues evaluated the efficacy of low-dose rituximab (1 g every 6 months) in a cohort of patients with RA. Of 361 patients in the initial registry, 81 achieved sustained low disease activity or remission on standard rituximab regimens and were transitioned to the low-dose regimen; their outcomes were compared with the 280 patients in the registry who received a standard-dose regimen. Only 7.5% experienced flares of RA (compared with 5.9% in the standard-dose group), and patients in the low-dose group had fewer serious adverse events, infections, and hospitalizations. Tapering biologic disease-modifying antirheumatic drugs (DMARD) may thus be a reasonable strategy for some patients with RA, with an eye to their prior results with the medication.

The prospect of achieving sustained DMARD-free remission (SDFR) in people with RA has seemed increasingly feasible in recent studies, although it seems to be affected by anti-citrullinated protein/peptide antibody (ACPA) positivity. That is, people who are ACPA-negative are more likely to reach this target. Verstappen and colleagues examined MRI patterns of joint inflammation in the Leiden Early Arthritis Clinic cohort, as well as another cohort of patients with RA, but only included patients with an RA duration > 1 year to reduce the likelihood of misclassification. Interestingly, ACPA-positive patients who achieved SDFR tended to have lower baseline evidence of joint inflammation (including erosions, synovitis, and osteitis), which was persistent throughout follow-up, whereas ACPA-negative patients who achieved SDFR had similar joint inflammation at baseline to those who did not, but had a better initial response to DMARD therapy. Further study of the potential impact of treatment based on ACPA status would be helpful.

Recent results from the ORAL Surveillance postmarketing safety analysis suggest that tofacitinib is associated with an increased risk for cancer in patients with RA patients who are aged >50 years, compared with anti–tumor necrosis factor (TNF) agents. Khosrow-Khavar and colleagues used insurance claims data to further investigate the risk for cancer with tofacitinib vs anti-TNF agents. They created two cohorts of patients who were new users of anti-TNF agents or tofacitinib: One was a "real-world" cohort including all patients with RA, whereas the other applied the inclusion and exclusion criteria from the ORAL Surveillance trial, including age >50 years, one cardiovascular risk factor, and use of methotrexate. Results from the real-world cohort, including over 10,000 patients who had used tofacitinib, did not show any increase in cancer risk, whereas the trial-simulating conditions did yield higher numbers of cancers in the group exposed to tofacitinib. Though reassuring, these results are limited by the short follow-up duration, and longer-term follow-up studies are necessary for further evaluation.

In another interesting note with respect to medication morbidity and risk, Xu and colleagues performed a meta-analysis looking at the association of methotrexate use and mortality in patients with RA. Only 15 studies were included in the final analysis, though they did encompass a large total number of patients. Overall, methotrexate use in these studies was associated with lower rates of overall mortality as well as mortality due to cardiovascular and interstitial lung disease. However, conclusions as to the direct impact of methotrexate were limited by the heterogeneity of study designs, doses of methotrexate, and additional therapy as well as comparators.

Inhibition of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway by JAK inhibitors is efficacious in psoriatic arthritis (PsA). On the basis of the results of the pivotal SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib, a selective JAK1 inhibitor, was recently approved for the treatment of PsA. However, data on longer-term disease control is still of interest. In a post hoc analysis of SELECT-PsA 1 and SELECT-PsA 2, Mease and colleagues assessed the proportion of patients achieving low disease activity or remission, as defined by validated measures such as the Disease Activity Index in Psoriatic Arthritis, Psoriatic Arthritis Disease Activity Scores, and minimal disease activity at 24 and 56 weeks. They showed that at week 24,a higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved low disease activityon the Disease Activity Index in Psoriatic Arthritis (range, 35%-48% vs 4%-16%; P< .05) and remission (range, 7%-11% vs 0%-3%; P< .05), with the responses sustained until week 56. Thus, upadacitinib provides sustained disease control in PsA and is an effective oral therapy.

Advanced targeted therapies have proven safety and efficacy over conventional therapies, often dramatically improving signs and symptoms. However, it is also desirable that such expensive therapies also show benefit in other outcomes, such as work productivity and quality of life. To evaluate work productivity and daily activity impairment and health-related quality of life in patients with inflammatory arthritis (rheumatoid arthritis, n=95;PsA,n=69, and axial spondyloarthritis, n=95) treated with golimumab, Dejaco and colleagues conducted a prospective, multicenter study in Austria. A total of 110 of these patients were followed for 24 months. At 24 months after golimumab initiation, there was significant improvement in total work productivity, presenteeism, activity impairment, and quality-of-life scores. Thus, golimumab, in addition to reducing disease activity, improved work productivity, activity, and health-related quality of life in patients with inflammatory arthritis, including PsA.

Cardiovascular disease (CVD) remains a major comorbidity in patients with PsA. This observation was once again confirmed in an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls from France. Degboe and colleagues demonstrated that patients with PsA had a higher prevalence of cardiovascular events and cardiovascular risk factors, such as high body mass index, triglyceride level, and hypertension, compared with controls. The proportion of patients with PsA who were estimated to have very high cardiovascular risk factors (≥10%) increased when SCORE (European Society of Cardiology Systematic Coronary Risk Evaluation) and QRISK2 (British Heart Foundation) equations considered the additional risk attributable to PsA. However, risk predictions scores such as SCORE and QRISK2 perform poorly in patients with PsA. To identify novel inflammatory and metabolic parameters associated with cardiovascular disease, Schwartz and colleagues looked at¹⁸F-fluorodeoxyglucose(FDG) PET-CT uptakeina cross-sectional analysis of a prospective study including 39 patients with biologic-treatment-naive PsA and 56 age-sex matched controls without PsA. They found that coronary artery disease (CAD) was significantly associated with visceral adiposity and FDG uptake in the bone marrow, liver, spleen, and subcutaneous adipose tissue. Thus, inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical CAD in patients with PsA and may in the future be used to refine CVD risk and be targets for CAD preventive treatments.

Inhibition of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway by JAK inhibitors is efficacious in psoriatic arthritis (PsA). On the basis of the results of the pivotal SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib, a selective JAK1 inhibitor, was recently approved for the treatment of PsA. However, data on longer-term disease control is still of interest. In a post hoc analysis of SELECT-PsA 1 and SELECT-PsA 2, Mease and colleagues assessed the proportion of patients achieving low disease activity or remission, as defined by validated measures such as the Disease Activity Index in Psoriatic Arthritis, Psoriatic Arthritis Disease Activity Scores, and minimal disease activity at 24 and 56 weeks. They showed that at week 24,a higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved low disease activityon the Disease Activity Index in Psoriatic Arthritis (range, 35%-48% vs 4%-16%; P< .05) and remission (range, 7%-11% vs 0%-3%; P< .05), with the responses sustained until week 56. Thus, upadacitinib provides sustained disease control in PsA and is an effective oral therapy.

Advanced targeted therapies have proven safety and efficacy over conventional therapies, often dramatically improving signs and symptoms. However, it is also desirable that such expensive therapies also show benefit in other outcomes, such as work productivity and quality of life. To evaluate work productivity and daily activity impairment and health-related quality of life in patients with inflammatory arthritis (rheumatoid arthritis, n=95;PsA,n=69, and axial spondyloarthritis, n=95) treated with golimumab, Dejaco and colleagues conducted a prospective, multicenter study in Austria. A total of 110 of these patients were followed for 24 months. At 24 months after golimumab initiation, there was significant improvement in total work productivity, presenteeism, activity impairment, and quality-of-life scores. Thus, golimumab, in addition to reducing disease activity, improved work productivity, activity, and health-related quality of life in patients with inflammatory arthritis, including PsA.

Cardiovascular disease (CVD) remains a major comorbidity in patients with PsA. This observation was once again confirmed in an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls from France. Degboe and colleagues demonstrated that patients with PsA had a higher prevalence of cardiovascular events and cardiovascular risk factors, such as high body mass index, triglyceride level, and hypertension, compared with controls. The proportion of patients with PsA who were estimated to have very high cardiovascular risk factors (≥10%) increased when SCORE (European Society of Cardiology Systematic Coronary Risk Evaluation) and QRISK2 (British Heart Foundation) equations considered the additional risk attributable to PsA. However, risk predictions scores such as SCORE and QRISK2 perform poorly in patients with PsA. To identify novel inflammatory and metabolic parameters associated with cardiovascular disease, Schwartz and colleagues looked at¹⁸F-fluorodeoxyglucose(FDG) PET-CT uptakeina cross-sectional analysis of a prospective study including 39 patients with biologic-treatment-naive PsA and 56 age-sex matched controls without PsA. They found that coronary artery disease (CAD) was significantly associated with visceral adiposity and FDG uptake in the bone marrow, liver, spleen, and subcutaneous adipose tissue. Thus, inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical CAD in patients with PsA and may in the future be used to refine CVD risk and be targets for CAD preventive treatments.

Inhibition of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway by JAK inhibitors is efficacious in psoriatic arthritis (PsA). On the basis of the results of the pivotal SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib, a selective JAK1 inhibitor, was recently approved for the treatment of PsA. However, data on longer-term disease control is still of interest. In a post hoc analysis of SELECT-PsA 1 and SELECT-PsA 2, Mease and colleagues assessed the proportion of patients achieving low disease activity or remission, as defined by validated measures such as the Disease Activity Index in Psoriatic Arthritis, Psoriatic Arthritis Disease Activity Scores, and minimal disease activity at 24 and 56 weeks. They showed that at week 24,a higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved low disease activityon the Disease Activity Index in Psoriatic Arthritis (range, 35%-48% vs 4%-16%; P< .05) and remission (range, 7%-11% vs 0%-3%; P< .05), with the responses sustained until week 56. Thus, upadacitinib provides sustained disease control in PsA and is an effective oral therapy.

Advanced targeted therapies have proven safety and efficacy over conventional therapies, often dramatically improving signs and symptoms. However, it is also desirable that such expensive therapies also show benefit in other outcomes, such as work productivity and quality of life. To evaluate work productivity and daily activity impairment and health-related quality of life in patients with inflammatory arthritis (rheumatoid arthritis, n=95;PsA,n=69, and axial spondyloarthritis, n=95) treated with golimumab, Dejaco and colleagues conducted a prospective, multicenter study in Austria. A total of 110 of these patients were followed for 24 months. At 24 months after golimumab initiation, there was significant improvement in total work productivity, presenteeism, activity impairment, and quality-of-life scores. Thus, golimumab, in addition to reducing disease activity, improved work productivity, activity, and health-related quality of life in patients with inflammatory arthritis, including PsA.

Cardiovascular disease (CVD) remains a major comorbidity in patients with PsA. This observation was once again confirmed in an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls from France. Degboe and colleagues demonstrated that patients with PsA had a higher prevalence of cardiovascular events and cardiovascular risk factors, such as high body mass index, triglyceride level, and hypertension, compared with controls. The proportion of patients with PsA who were estimated to have very high cardiovascular risk factors (≥10%) increased when SCORE (European Society of Cardiology Systematic Coronary Risk Evaluation) and QRISK2 (British Heart Foundation) equations considered the additional risk attributable to PsA. However, risk predictions scores such as SCORE and QRISK2 perform poorly in patients with PsA. To identify novel inflammatory and metabolic parameters associated with cardiovascular disease, Schwartz and colleagues looked at¹⁸F-fluorodeoxyglucose(FDG) PET-CT uptakeina cross-sectional analysis of a prospective study including 39 patients with biologic-treatment-naive PsA and 56 age-sex matched controls without PsA. They found that coronary artery disease (CAD) was significantly associated with visceral adiposity and FDG uptake in the bone marrow, liver, spleen, and subcutaneous adipose tissue. Thus, inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical CAD in patients with PsA and may in the future be used to refine CVD risk and be targets for CAD preventive treatments.

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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