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Severe psoriasis linked to a higher risk for heart disease, study confirms
TOPLINE:
METHODOLOGY:
- Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
- In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
- The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
- The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.
TAKEAWAY:
- Of the 448 patients, 141 (31.5%) showed CMD.
- Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
- An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.
IN PRACTICE:
“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.
SOURCE:
Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.
LIMITATIONS:
A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.
DISCLOSURES:
The authors reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
- In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
- The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
- The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.
TAKEAWAY:
- Of the 448 patients, 141 (31.5%) showed CMD.
- Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
- An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.
IN PRACTICE:
“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.
SOURCE:
Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.
LIMITATIONS:
A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.
DISCLOSURES:
The authors reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Prior studies with small sample sizes have shown that CMD predicts poor cardiovascular outcomes in patients with severe psoriasis.
- In a prospective multicenter study, researchers enrolled 448 patients with moderate to severe psoriasis with no documented clinical cardiovascular disease who underwent transthoracic Doppler echocardiography to evaluate coronary microcirculation.
- The outcome variable of interest was CMD, defined as a coronary flow rate of 2.5 mL or less.
- The researchers used multivariable linear regression to model the associations of the characteristics of patients with psoriasis with CMD.
TAKEAWAY:
- Of the 448 patients, 141 (31.5%) showed CMD.
- Multivariable regression revealed four variables independently associated with CMD: higher Psoriasis Area Severity Index (PASI) score (per unit, odds ratio, 1.058; P < .001), duration of psoriasis (per year; OR, 1.046; P < .001), the presence of psoriatic arthritis (OR, 1.938; P = .015), and hypertension (OR, 2.169; P = .010).
- An increase of 1 point in the PASI score and 1 year of psoriasis duration were associated with a 5.8% and a 4.6% increased risk for CMD, respectively.
IN PRACTICE:
“We should diagnose and actively search for microvascular dysfunction in patients with psoriasis, as this population is at particularly high risk,” the researchers wrote.
SOURCE:
Stefano Piaserico, MD, PhD, of the University of Padova (Italy), led the research. The study was published in the Journal of Investigative Dermatology.
LIMITATIONS:
A small proportion of patients in the study were being treated for psoriasis, and other tools for assessing CMD were not used, such as PET-CT and cardiovascular MRI.
DISCLOSURES:
The authors reported having no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Comorbidities, CV risk factors common in early PsA
TOPLINE:
Patients with early psoriatic arthritis (PsA) were significantly more likely to have multiple comorbidities and cardiovascular risk factors than controls.
METHODOLOGY:
- The study population included 67 adults with early PsA and 61 healthy matched controls with mean ages of 47.9 years and 45 years, respectively.
- Early PsA was defined as symptom duration of less than 2 years; patients with conditions including active infection, malignancy, or other rheumatic or systemic disease were excluded.
- The researchers examined the prevalence of comorbidities and cardiovascular risk factors in treatment-naive, newly diagnosed patients with PsA at baseline and after 1 year.
TAKEAWAY:
- , compared with healthy controls (odds ratios, 1.9 and 2.1, respectively).
- Dyslipidemia was the most prevalent comorbidity among patients with PsA and was more prevalent than in controls (64.2% vs. 39.3%; OR, 1.7).
- Obesity was more common in patients with PsA, compared with controls (40.3% vs. 18.3%, respectively), and more patients with PsA had cardiovascular disease at baseline than did controls (20.9% vs. 6.6%; OR, 3.2).
- Disease activity scores improved after 1 year, but the proportion of patients with comorbidities and CV risk factors remained stable.
IN PRACTICE:
The results support the early assessment of patients with PsA for comorbidities to inform treatment and suggest that comorbidities and CV risk factors are more than a consequence of long-term PsA and chronic systemic inflammation.
SOURCE:
The study was conducted by Alla Ishchenko, MD, and colleagues in the division of rheumatology at University Hospitals Leuven, Belgium. The study was published online in Arthritis Care & Research.
LIMITATIONS:
The study was exploratory in nature, with a short follow-up period and a relatively small sample size.
DISCLOSURES:
Dr. Ishchenko disclosed support from PARTNER, an international fellowship program to study disease mechanisms in psoriatic arthritis, as well as grants from Lilly and from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with early psoriatic arthritis (PsA) were significantly more likely to have multiple comorbidities and cardiovascular risk factors than controls.
METHODOLOGY:
- The study population included 67 adults with early PsA and 61 healthy matched controls with mean ages of 47.9 years and 45 years, respectively.
- Early PsA was defined as symptom duration of less than 2 years; patients with conditions including active infection, malignancy, or other rheumatic or systemic disease were excluded.
- The researchers examined the prevalence of comorbidities and cardiovascular risk factors in treatment-naive, newly diagnosed patients with PsA at baseline and after 1 year.
TAKEAWAY:
- , compared with healthy controls (odds ratios, 1.9 and 2.1, respectively).
- Dyslipidemia was the most prevalent comorbidity among patients with PsA and was more prevalent than in controls (64.2% vs. 39.3%; OR, 1.7).
- Obesity was more common in patients with PsA, compared with controls (40.3% vs. 18.3%, respectively), and more patients with PsA had cardiovascular disease at baseline than did controls (20.9% vs. 6.6%; OR, 3.2).
- Disease activity scores improved after 1 year, but the proportion of patients with comorbidities and CV risk factors remained stable.
IN PRACTICE:
The results support the early assessment of patients with PsA for comorbidities to inform treatment and suggest that comorbidities and CV risk factors are more than a consequence of long-term PsA and chronic systemic inflammation.
SOURCE:
The study was conducted by Alla Ishchenko, MD, and colleagues in the division of rheumatology at University Hospitals Leuven, Belgium. The study was published online in Arthritis Care & Research.
LIMITATIONS:
The study was exploratory in nature, with a short follow-up period and a relatively small sample size.
DISCLOSURES:
Dr. Ishchenko disclosed support from PARTNER, an international fellowship program to study disease mechanisms in psoriatic arthritis, as well as grants from Lilly and from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with early psoriatic arthritis (PsA) were significantly more likely to have multiple comorbidities and cardiovascular risk factors than controls.
METHODOLOGY:
- The study population included 67 adults with early PsA and 61 healthy matched controls with mean ages of 47.9 years and 45 years, respectively.
- Early PsA was defined as symptom duration of less than 2 years; patients with conditions including active infection, malignancy, or other rheumatic or systemic disease were excluded.
- The researchers examined the prevalence of comorbidities and cardiovascular risk factors in treatment-naive, newly diagnosed patients with PsA at baseline and after 1 year.
TAKEAWAY:
- , compared with healthy controls (odds ratios, 1.9 and 2.1, respectively).
- Dyslipidemia was the most prevalent comorbidity among patients with PsA and was more prevalent than in controls (64.2% vs. 39.3%; OR, 1.7).
- Obesity was more common in patients with PsA, compared with controls (40.3% vs. 18.3%, respectively), and more patients with PsA had cardiovascular disease at baseline than did controls (20.9% vs. 6.6%; OR, 3.2).
- Disease activity scores improved after 1 year, but the proportion of patients with comorbidities and CV risk factors remained stable.
IN PRACTICE:
The results support the early assessment of patients with PsA for comorbidities to inform treatment and suggest that comorbidities and CV risk factors are more than a consequence of long-term PsA and chronic systemic inflammation.
SOURCE:
The study was conducted by Alla Ishchenko, MD, and colleagues in the division of rheumatology at University Hospitals Leuven, Belgium. The study was published online in Arthritis Care & Research.
LIMITATIONS:
The study was exploratory in nature, with a short follow-up period and a relatively small sample size.
DISCLOSURES:
Dr. Ishchenko disclosed support from PARTNER, an international fellowship program to study disease mechanisms in psoriatic arthritis, as well as grants from Lilly and from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
A version of this article first appeared on Medscape.com.
PsA Complications
Medicare announces 10 drugs targeted for price cuts in 2026
People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.
It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.
While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.
CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
- Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
- Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
- Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
- Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
- Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
- Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
- Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
- Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
- Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.
A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.
“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.
According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.
Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.
The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.
Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.
In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.
This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).
Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.
“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.
In addition, AARP issued a statement of its continued support for Medicare drug negotiations.
“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”
A version of this article first appeared on Medscape.com.
People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.
It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.
While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.
CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
- Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
- Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
- Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
- Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
- Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
- Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
- Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
- Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
- Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.
A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.
“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.
According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.
Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.
The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.
Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.
In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.
This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).
Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.
“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.
In addition, AARP issued a statement of its continued support for Medicare drug negotiations.
“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”
A version of this article first appeared on Medscape.com.
People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.
It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.
While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.
CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
- Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
- Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
- Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
- Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
- Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
- Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
- Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
- Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
- Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.
A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.
“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.
According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.
Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.
The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.
Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.
In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.
This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).
Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.
“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.
In addition, AARP issued a statement of its continued support for Medicare drug negotiations.
“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”
A version of this article first appeared on Medscape.com.
Rheumatology trials seem vulnerable to unblinding: Report
Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.
“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.
Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
A sample of pivotal clinical trials
The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.
The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.
In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:
- High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
- Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
- Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).
Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
Unblinding risk to clinical trial validity
CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.
“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.
The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.
But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.
“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.
In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.
“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
Unblinding measure needs validation
In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”
He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.
“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”
Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”
In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.
There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.
“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.
In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”
One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.
“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.
In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.
Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.
Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.
“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.
Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
A sample of pivotal clinical trials
The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.
The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.
In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:
- High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
- Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
- Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).
Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
Unblinding risk to clinical trial validity
CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.
“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.
The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.
But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.
“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.
In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.
“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
Unblinding measure needs validation
In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”
He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.
“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”
Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”
In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.
There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.
“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.
In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”
One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.
“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.
In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.
Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.
Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.
“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.
Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
A sample of pivotal clinical trials
The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.
The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.
In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:
- High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
- Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
- Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).
Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
Unblinding risk to clinical trial validity
CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.
“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.
The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.
But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.
“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.
In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.
“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
Unblinding measure needs validation
In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”
He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.
“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”
Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”
In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.
There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.
“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.
In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”
One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.
“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.
In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.
Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.
FROM THE LANCET RHEUMATOLOGY
Commentary: Genetics, Juvenile PsA, and Weight Loss in PsA, September 2023
A large majority of patients with psoriatic arthritis (PsA) develop inflammatory musculoskeletal disease after the onset of cutaneous psoriasis. Identifying molecular markers and mechanisms underlying the transition from psoriasis alone to PsA can help develop tools for early diagnosis as well as preventive interventions. With the aim of identifying epigenetic markers that predict PsA in patients with psoriasis, Cruz-Correa and colleagues this month reported the results of a nested case-control study that included 58 patients with psoriasis who later developed PsA matched to 59 patients who did not develop PsA. They conducted genome-wide DNA methylation analyses on blood samples from the patients recruited for this study. Their predictive model, based on 36 highly relevant methylation markers across 15 genes and intergenic regions (including FBXO27 and ZNF385D), could identify patients with psoriasis who developed PsA from those who did not, with an excellent AUC (area under the receiver operating characteristic curve) of 0.964. These results are exciting but require further internal and external validation.
Although the usual age at onset of PsA is in the fourth or fifth decade of life, children may develop juvenile-onset PsA (JPsA). Less attention has been paid to this form of juvenile idiopathic arthritis (JIA), and the impact of JPsA vis-à-vis other forms of JIA is not well known. In addition, only about half of the patients with JPsA have cutaneous psoriasis. The impact of psoriasis on children with JPsA is not known. In order to evaluate differences in disease outcomes in patients with JPsA, Low and colleagues evaluated 1653 children and young people with JIA who were recruited to the Childhood Arthritis Prospective Study, of whom 111 had JPsA at diagnosis. They demonstrated that there were no significant differences in patient-reported outcomes between children with JPsA and other JIA categories. However, children with JPsA and psoriasis at JPsA diagnosis had more depressive symptoms compared with those without psoriasis. Moreover, children with JPsA vs other JIA categories had 2.35 times higher odds of having persistently poor well-being scores despite improvements in joint counts and physician global scores. Thus, children with JPsA have poorer well-being scores and a higher prevalence of depression, which requires multidisciplinary care.
Apart from immunomodulatory therapies, weight loss leads to improvement in disease activity in patients with obesity and PsA. However, the mechanisms by which weight loss improves PsA is currently not known, but is likely to be due to changes in adipokines and inflammation-related cytokines. In a recent study1that included patients with PsA and obesity, it was demonstrated that weight loss through a Very Low Energy Diet (VLED) resulted in significant improvements in PsA disease activity. Landgren and colleagues now aimed to determine the effects of VLED on cytokines and adipokines. They obtained blood samples from patients with PsA and obesity (n = 41) and matched control individuals without rheumatic disease or psoriasis (n = 39) who were on VLED. At month 6, along with significant weight loss, serum levels of interleukin-23 and leptin decreased significantly, while those of total adiponectin and high-molecular-weight adiponectin increased significantly in patients with PsA and control individuals. The change in body mass index correlated positively with a reduction in serum interleukin-23 (rS = 0.671, P < .001) and improvement in PsA disease activity (P = .003). This study highlights the anti-inflammatory effect of weight loss in patients with PsA. Weight loss can complement immunomodulatory therapy in PsA patients with obesity.
Additional Reference
- Klingberg E, Bilberg A, Björkman S, et al. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019;21:17. doi: 10.1186/s13075-019-1810-5
A large majority of patients with psoriatic arthritis (PsA) develop inflammatory musculoskeletal disease after the onset of cutaneous psoriasis. Identifying molecular markers and mechanisms underlying the transition from psoriasis alone to PsA can help develop tools for early diagnosis as well as preventive interventions. With the aim of identifying epigenetic markers that predict PsA in patients with psoriasis, Cruz-Correa and colleagues this month reported the results of a nested case-control study that included 58 patients with psoriasis who later developed PsA matched to 59 patients who did not develop PsA. They conducted genome-wide DNA methylation analyses on blood samples from the patients recruited for this study. Their predictive model, based on 36 highly relevant methylation markers across 15 genes and intergenic regions (including FBXO27 and ZNF385D), could identify patients with psoriasis who developed PsA from those who did not, with an excellent AUC (area under the receiver operating characteristic curve) of 0.964. These results are exciting but require further internal and external validation.
Although the usual age at onset of PsA is in the fourth or fifth decade of life, children may develop juvenile-onset PsA (JPsA). Less attention has been paid to this form of juvenile idiopathic arthritis (JIA), and the impact of JPsA vis-à-vis other forms of JIA is not well known. In addition, only about half of the patients with JPsA have cutaneous psoriasis. The impact of psoriasis on children with JPsA is not known. In order to evaluate differences in disease outcomes in patients with JPsA, Low and colleagues evaluated 1653 children and young people with JIA who were recruited to the Childhood Arthritis Prospective Study, of whom 111 had JPsA at diagnosis. They demonstrated that there were no significant differences in patient-reported outcomes between children with JPsA and other JIA categories. However, children with JPsA and psoriasis at JPsA diagnosis had more depressive symptoms compared with those without psoriasis. Moreover, children with JPsA vs other JIA categories had 2.35 times higher odds of having persistently poor well-being scores despite improvements in joint counts and physician global scores. Thus, children with JPsA have poorer well-being scores and a higher prevalence of depression, which requires multidisciplinary care.
Apart from immunomodulatory therapies, weight loss leads to improvement in disease activity in patients with obesity and PsA. However, the mechanisms by which weight loss improves PsA is currently not known, but is likely to be due to changes in adipokines and inflammation-related cytokines. In a recent study1that included patients with PsA and obesity, it was demonstrated that weight loss through a Very Low Energy Diet (VLED) resulted in significant improvements in PsA disease activity. Landgren and colleagues now aimed to determine the effects of VLED on cytokines and adipokines. They obtained blood samples from patients with PsA and obesity (n = 41) and matched control individuals without rheumatic disease or psoriasis (n = 39) who were on VLED. At month 6, along with significant weight loss, serum levels of interleukin-23 and leptin decreased significantly, while those of total adiponectin and high-molecular-weight adiponectin increased significantly in patients with PsA and control individuals. The change in body mass index correlated positively with a reduction in serum interleukin-23 (rS = 0.671, P < .001) and improvement in PsA disease activity (P = .003). This study highlights the anti-inflammatory effect of weight loss in patients with PsA. Weight loss can complement immunomodulatory therapy in PsA patients with obesity.
Additional Reference
- Klingberg E, Bilberg A, Björkman S, et al. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019;21:17. doi: 10.1186/s13075-019-1810-5
A large majority of patients with psoriatic arthritis (PsA) develop inflammatory musculoskeletal disease after the onset of cutaneous psoriasis. Identifying molecular markers and mechanisms underlying the transition from psoriasis alone to PsA can help develop tools for early diagnosis as well as preventive interventions. With the aim of identifying epigenetic markers that predict PsA in patients with psoriasis, Cruz-Correa and colleagues this month reported the results of a nested case-control study that included 58 patients with psoriasis who later developed PsA matched to 59 patients who did not develop PsA. They conducted genome-wide DNA methylation analyses on blood samples from the patients recruited for this study. Their predictive model, based on 36 highly relevant methylation markers across 15 genes and intergenic regions (including FBXO27 and ZNF385D), could identify patients with psoriasis who developed PsA from those who did not, with an excellent AUC (area under the receiver operating characteristic curve) of 0.964. These results are exciting but require further internal and external validation.
Although the usual age at onset of PsA is in the fourth or fifth decade of life, children may develop juvenile-onset PsA (JPsA). Less attention has been paid to this form of juvenile idiopathic arthritis (JIA), and the impact of JPsA vis-à-vis other forms of JIA is not well known. In addition, only about half of the patients with JPsA have cutaneous psoriasis. The impact of psoriasis on children with JPsA is not known. In order to evaluate differences in disease outcomes in patients with JPsA, Low and colleagues evaluated 1653 children and young people with JIA who were recruited to the Childhood Arthritis Prospective Study, of whom 111 had JPsA at diagnosis. They demonstrated that there were no significant differences in patient-reported outcomes between children with JPsA and other JIA categories. However, children with JPsA and psoriasis at JPsA diagnosis had more depressive symptoms compared with those without psoriasis. Moreover, children with JPsA vs other JIA categories had 2.35 times higher odds of having persistently poor well-being scores despite improvements in joint counts and physician global scores. Thus, children with JPsA have poorer well-being scores and a higher prevalence of depression, which requires multidisciplinary care.
Apart from immunomodulatory therapies, weight loss leads to improvement in disease activity in patients with obesity and PsA. However, the mechanisms by which weight loss improves PsA is currently not known, but is likely to be due to changes in adipokines and inflammation-related cytokines. In a recent study1that included patients with PsA and obesity, it was demonstrated that weight loss through a Very Low Energy Diet (VLED) resulted in significant improvements in PsA disease activity. Landgren and colleagues now aimed to determine the effects of VLED on cytokines and adipokines. They obtained blood samples from patients with PsA and obesity (n = 41) and matched control individuals without rheumatic disease or psoriasis (n = 39) who were on VLED. At month 6, along with significant weight loss, serum levels of interleukin-23 and leptin decreased significantly, while those of total adiponectin and high-molecular-weight adiponectin increased significantly in patients with PsA and control individuals. The change in body mass index correlated positively with a reduction in serum interleukin-23 (rS = 0.671, P < .001) and improvement in PsA disease activity (P = .003). This study highlights the anti-inflammatory effect of weight loss in patients with PsA. Weight loss can complement immunomodulatory therapy in PsA patients with obesity.
Additional Reference
- Klingberg E, Bilberg A, Björkman S, et al. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019;21:17. doi: 10.1186/s13075-019-1810-5
Structural changes may separate axial psoriatic arthritis from axial spondyloarthritis
Approximately 20% of adults with axial psoriatic arthritis (PsA) show active or structural spinal changes without changes in the sacroiliac joint, based on imaging data from 106 individuals.
Axial PsA has been historically grouped with axial spondyloarthritis (axSpA), but it has received more attention in recent years as a condition potentially distinct from axSpA, Henriette Käding, an MD and PhD student in the department of gastroenterology, infectiology, and rheumatology at Charité-Universitätsmedizin Berlin, said in her research presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). She added that the debate persists as to whether these conditions are on the same spectrum or should be separated.
Data from previous studies suggest differences in genetic, clinical, radiographic, and prognostic characteristics between axial PsA and axSpA that may affect patients’ response to available treatments. However, there are relatively little data available on distinguishing imaging and clinical features, and there’s a lack of classification criteria for axial PsA, Ms. Käding said.
Ms. Käding and colleagues prospectively collected data from 106 patients with axial PsA between August 2019 and June 2023 and presented the baseline data of this longitudinal project at the GRAPPA annual meeting in Dublin. At baseline, the researchers conducted clinical assessments of the participants, along with blood sampling, stool samples, and imaging protocols that included MRI of the whole spine and sacroiliac joint (SIJ).
The mean age of the included patients was 44.5 years; 55.7% were female. Inflammatory back pain was present in most of the patients at baseline (78.4%), and 48.1% were positive for HLA-B27, a genetic risk factor for both axSpA and axial PsA. Approximately one-third of the patients had elevated C-reactive protein (> 5 mg/L). In the baseline MRI scans, active inflammatory changes in the sacroiliac joints (SIJ) were seen in 51.9% of the patients and structural changes in 72.1%. MRI spine scans showed active changes in 58.7% of the patients. Notably, active and/or structural changes of the spine without changes in the SIJ appeared in 20% of the patients, Ms. Käding said.
With regard to existing classification criteria, the researchers observed that 92% of the patients met the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria for PsA, 73% met the ASAS (Assessment of Spondyloarthritis International Society) criteria, while 66% of patients met both ASAS and CASPAR criteria.
The study will be the first to include longitudinal MRI scans of the whole spine and SIJ in addition to conventional radiographs, Ms. Käding said.
Better characterization should improve treatment
“Axial involvement in PsA might, on one hand, go unnoticed, but on the other hand, it could also be misdiagnosed in patients with degenerative spinal disease,” Denis Poddubnyy, MD, one of the study coauthors, also of Charité-Universitätsmedizin Berlin, said in an interview.
“By comprehending the unique characteristics, progression, and treatment responses within the axial domain, rheumatologists can customize interventions and therapies to effectively manage the psoriatic disease,” Dr. Poddubnyy said.
“One of the most significant findings [of the current study] is the relatively high frequency of spinal involvement without sacroiliac joint” involvement, Fabian Proft, MD, of Charité-Universitätsmedizin Berlin and senior author of the study, said in an interview. “This finding holds importance as, in primary axial SpA, the disease typically originates in the sacroiliac joints. In contrast, in PsA, the scenario differs, which has implications for the diagnostic approach in clinical practice.”
“In individuals with PsA, spinal involvement can occur independently of sacroiliac joint [involvement]. As a result, imaging studies conducted on patients suspected of having axial PsA should encompass not only the sacroiliac joints but also the spine,” Dr. Poddubnyy explained. “It is important to note, however, that imaging findings such as bony spurs and bone marrow edema might be caused by degeneration or mechanical issues and, therefore, need to be interpreted with caution within the clinical context.”
The study was supported in part by an unrestricted research grant from Novartis. Dr. Poddubnyy and Dr. Proft disclosed receiving research grants and consultancy payments from Novartis and serving on speaker bureaus for the company.
Approximately 20% of adults with axial psoriatic arthritis (PsA) show active or structural spinal changes without changes in the sacroiliac joint, based on imaging data from 106 individuals.
Axial PsA has been historically grouped with axial spondyloarthritis (axSpA), but it has received more attention in recent years as a condition potentially distinct from axSpA, Henriette Käding, an MD and PhD student in the department of gastroenterology, infectiology, and rheumatology at Charité-Universitätsmedizin Berlin, said in her research presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). She added that the debate persists as to whether these conditions are on the same spectrum or should be separated.
Data from previous studies suggest differences in genetic, clinical, radiographic, and prognostic characteristics between axial PsA and axSpA that may affect patients’ response to available treatments. However, there are relatively little data available on distinguishing imaging and clinical features, and there’s a lack of classification criteria for axial PsA, Ms. Käding said.
Ms. Käding and colleagues prospectively collected data from 106 patients with axial PsA between August 2019 and June 2023 and presented the baseline data of this longitudinal project at the GRAPPA annual meeting in Dublin. At baseline, the researchers conducted clinical assessments of the participants, along with blood sampling, stool samples, and imaging protocols that included MRI of the whole spine and sacroiliac joint (SIJ).
The mean age of the included patients was 44.5 years; 55.7% were female. Inflammatory back pain was present in most of the patients at baseline (78.4%), and 48.1% were positive for HLA-B27, a genetic risk factor for both axSpA and axial PsA. Approximately one-third of the patients had elevated C-reactive protein (> 5 mg/L). In the baseline MRI scans, active inflammatory changes in the sacroiliac joints (SIJ) were seen in 51.9% of the patients and structural changes in 72.1%. MRI spine scans showed active changes in 58.7% of the patients. Notably, active and/or structural changes of the spine without changes in the SIJ appeared in 20% of the patients, Ms. Käding said.
With regard to existing classification criteria, the researchers observed that 92% of the patients met the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria for PsA, 73% met the ASAS (Assessment of Spondyloarthritis International Society) criteria, while 66% of patients met both ASAS and CASPAR criteria.
The study will be the first to include longitudinal MRI scans of the whole spine and SIJ in addition to conventional radiographs, Ms. Käding said.
Better characterization should improve treatment
“Axial involvement in PsA might, on one hand, go unnoticed, but on the other hand, it could also be misdiagnosed in patients with degenerative spinal disease,” Denis Poddubnyy, MD, one of the study coauthors, also of Charité-Universitätsmedizin Berlin, said in an interview.
“By comprehending the unique characteristics, progression, and treatment responses within the axial domain, rheumatologists can customize interventions and therapies to effectively manage the psoriatic disease,” Dr. Poddubnyy said.
“One of the most significant findings [of the current study] is the relatively high frequency of spinal involvement without sacroiliac joint” involvement, Fabian Proft, MD, of Charité-Universitätsmedizin Berlin and senior author of the study, said in an interview. “This finding holds importance as, in primary axial SpA, the disease typically originates in the sacroiliac joints. In contrast, in PsA, the scenario differs, which has implications for the diagnostic approach in clinical practice.”
“In individuals with PsA, spinal involvement can occur independently of sacroiliac joint [involvement]. As a result, imaging studies conducted on patients suspected of having axial PsA should encompass not only the sacroiliac joints but also the spine,” Dr. Poddubnyy explained. “It is important to note, however, that imaging findings such as bony spurs and bone marrow edema might be caused by degeneration or mechanical issues and, therefore, need to be interpreted with caution within the clinical context.”
The study was supported in part by an unrestricted research grant from Novartis. Dr. Poddubnyy and Dr. Proft disclosed receiving research grants and consultancy payments from Novartis and serving on speaker bureaus for the company.
Approximately 20% of adults with axial psoriatic arthritis (PsA) show active or structural spinal changes without changes in the sacroiliac joint, based on imaging data from 106 individuals.
Axial PsA has been historically grouped with axial spondyloarthritis (axSpA), but it has received more attention in recent years as a condition potentially distinct from axSpA, Henriette Käding, an MD and PhD student in the department of gastroenterology, infectiology, and rheumatology at Charité-Universitätsmedizin Berlin, said in her research presentation at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). She added that the debate persists as to whether these conditions are on the same spectrum or should be separated.
Data from previous studies suggest differences in genetic, clinical, radiographic, and prognostic characteristics between axial PsA and axSpA that may affect patients’ response to available treatments. However, there are relatively little data available on distinguishing imaging and clinical features, and there’s a lack of classification criteria for axial PsA, Ms. Käding said.
Ms. Käding and colleagues prospectively collected data from 106 patients with axial PsA between August 2019 and June 2023 and presented the baseline data of this longitudinal project at the GRAPPA annual meeting in Dublin. At baseline, the researchers conducted clinical assessments of the participants, along with blood sampling, stool samples, and imaging protocols that included MRI of the whole spine and sacroiliac joint (SIJ).
The mean age of the included patients was 44.5 years; 55.7% were female. Inflammatory back pain was present in most of the patients at baseline (78.4%), and 48.1% were positive for HLA-B27, a genetic risk factor for both axSpA and axial PsA. Approximately one-third of the patients had elevated C-reactive protein (> 5 mg/L). In the baseline MRI scans, active inflammatory changes in the sacroiliac joints (SIJ) were seen in 51.9% of the patients and structural changes in 72.1%. MRI spine scans showed active changes in 58.7% of the patients. Notably, active and/or structural changes of the spine without changes in the SIJ appeared in 20% of the patients, Ms. Käding said.
With regard to existing classification criteria, the researchers observed that 92% of the patients met the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria for PsA, 73% met the ASAS (Assessment of Spondyloarthritis International Society) criteria, while 66% of patients met both ASAS and CASPAR criteria.
The study will be the first to include longitudinal MRI scans of the whole spine and SIJ in addition to conventional radiographs, Ms. Käding said.
Better characterization should improve treatment
“Axial involvement in PsA might, on one hand, go unnoticed, but on the other hand, it could also be misdiagnosed in patients with degenerative spinal disease,” Denis Poddubnyy, MD, one of the study coauthors, also of Charité-Universitätsmedizin Berlin, said in an interview.
“By comprehending the unique characteristics, progression, and treatment responses within the axial domain, rheumatologists can customize interventions and therapies to effectively manage the psoriatic disease,” Dr. Poddubnyy said.
“One of the most significant findings [of the current study] is the relatively high frequency of spinal involvement without sacroiliac joint” involvement, Fabian Proft, MD, of Charité-Universitätsmedizin Berlin and senior author of the study, said in an interview. “This finding holds importance as, in primary axial SpA, the disease typically originates in the sacroiliac joints. In contrast, in PsA, the scenario differs, which has implications for the diagnostic approach in clinical practice.”
“In individuals with PsA, spinal involvement can occur independently of sacroiliac joint [involvement]. As a result, imaging studies conducted on patients suspected of having axial PsA should encompass not only the sacroiliac joints but also the spine,” Dr. Poddubnyy explained. “It is important to note, however, that imaging findings such as bony spurs and bone marrow edema might be caused by degeneration or mechanical issues and, therefore, need to be interpreted with caution within the clinical context.”
The study was supported in part by an unrestricted research grant from Novartis. Dr. Poddubnyy and Dr. Proft disclosed receiving research grants and consultancy payments from Novartis and serving on speaker bureaus for the company.
FROM GRAPPA 2023
Cardiometabolic multimorbidity positively impacts secukinumab treatment persistence in PsA
Key clinical point: The presence of cardiometabolic multimorbidity may be associated with an improved treatment persistence with secukinumab in patients with psoriatic arthritis (PsA).
Major finding: The cumulative 60-month drug retention rate for secukinumab was 57.0% in patients with cardiometabolic multimorbidity (P = .042). Those with type 2 diabetes had a significantly better drug retention rate than those without (P = .044).
Study details: Findings are from a retrospective study of prospectively followed-up patients with PsA (n = 207) who received secukinumab for at least 3 months.
Disclosures: The study did not disclose the source of funding. The authors declared no conflicts of interest.
Source: Ruscitti P et al. The assessment of the drug retention rate of secukinumab in patients with psoriatic arthritis in a real-life multicentre cohort. Clin Exp Rheumatol. 2023 (Jul 24). doi: 10.55563/clinexprheumatol/tpp63h
Key clinical point: The presence of cardiometabolic multimorbidity may be associated with an improved treatment persistence with secukinumab in patients with psoriatic arthritis (PsA).
Major finding: The cumulative 60-month drug retention rate for secukinumab was 57.0% in patients with cardiometabolic multimorbidity (P = .042). Those with type 2 diabetes had a significantly better drug retention rate than those without (P = .044).
Study details: Findings are from a retrospective study of prospectively followed-up patients with PsA (n = 207) who received secukinumab for at least 3 months.
Disclosures: The study did not disclose the source of funding. The authors declared no conflicts of interest.
Source: Ruscitti P et al. The assessment of the drug retention rate of secukinumab in patients with psoriatic arthritis in a real-life multicentre cohort. Clin Exp Rheumatol. 2023 (Jul 24). doi: 10.55563/clinexprheumatol/tpp63h
Key clinical point: The presence of cardiometabolic multimorbidity may be associated with an improved treatment persistence with secukinumab in patients with psoriatic arthritis (PsA).
Major finding: The cumulative 60-month drug retention rate for secukinumab was 57.0% in patients with cardiometabolic multimorbidity (P = .042). Those with type 2 diabetes had a significantly better drug retention rate than those without (P = .044).
Study details: Findings are from a retrospective study of prospectively followed-up patients with PsA (n = 207) who received secukinumab for at least 3 months.
Disclosures: The study did not disclose the source of funding. The authors declared no conflicts of interest.
Source: Ruscitti P et al. The assessment of the drug retention rate of secukinumab in patients with psoriatic arthritis in a real-life multicentre cohort. Clin Exp Rheumatol. 2023 (Jul 24). doi: 10.55563/clinexprheumatol/tpp63h
Real-world study confirms efficacy and longer treatment persistence with ixekizumab
Key clinical point: In the real-world setting, ixekizumab showed improvements in disease activity and treatment persistence in patients with psoriatic arthritis (PsA) with long-standing disease.
Major finding: The mean time of ixekizumab persistence was 86.9 weeks with the persistence rates at 24, 48, and 104 weeks being 95.5%, 84.3%, and 68.5%, respectively. The Disease Activity in Psoriatic Arthritis score reduced significantly from 23.7 at baseline to 14.8 (P = .005) and 14.3 (P = .004) at 12 and 24 weeks, respectively, of ixekizumab treatment.
Study details: Findings are from an observational, retrospective longitudinal study including 89 adult patients with PsA who initiated ixekizumab.
Disclosures: This study was funded by Eli Lilly & Co. Three authors declared being employees of Lilly and two authors reported employment with a consulting company funded by Lilly. Five authors reported ties with various sources, including Lilly. Other authors declared no conflicts of interest.
Source: Joven B et al. Persistence and use of Ixekizumab in patients with psoriatic arthritis in real-world practice in Spain. The PRO-STIP Study. Rheumatol Ther. 2023 (Jul 23). doi: 10.1007/s40744-023-00584-8
Key clinical point: In the real-world setting, ixekizumab showed improvements in disease activity and treatment persistence in patients with psoriatic arthritis (PsA) with long-standing disease.
Major finding: The mean time of ixekizumab persistence was 86.9 weeks with the persistence rates at 24, 48, and 104 weeks being 95.5%, 84.3%, and 68.5%, respectively. The Disease Activity in Psoriatic Arthritis score reduced significantly from 23.7 at baseline to 14.8 (P = .005) and 14.3 (P = .004) at 12 and 24 weeks, respectively, of ixekizumab treatment.
Study details: Findings are from an observational, retrospective longitudinal study including 89 adult patients with PsA who initiated ixekizumab.
Disclosures: This study was funded by Eli Lilly & Co. Three authors declared being employees of Lilly and two authors reported employment with a consulting company funded by Lilly. Five authors reported ties with various sources, including Lilly. Other authors declared no conflicts of interest.
Source: Joven B et al. Persistence and use of Ixekizumab in patients with psoriatic arthritis in real-world practice in Spain. The PRO-STIP Study. Rheumatol Ther. 2023 (Jul 23). doi: 10.1007/s40744-023-00584-8
Key clinical point: In the real-world setting, ixekizumab showed improvements in disease activity and treatment persistence in patients with psoriatic arthritis (PsA) with long-standing disease.
Major finding: The mean time of ixekizumab persistence was 86.9 weeks with the persistence rates at 24, 48, and 104 weeks being 95.5%, 84.3%, and 68.5%, respectively. The Disease Activity in Psoriatic Arthritis score reduced significantly from 23.7 at baseline to 14.8 (P = .005) and 14.3 (P = .004) at 12 and 24 weeks, respectively, of ixekizumab treatment.
Study details: Findings are from an observational, retrospective longitudinal study including 89 adult patients with PsA who initiated ixekizumab.
Disclosures: This study was funded by Eli Lilly & Co. Three authors declared being employees of Lilly and two authors reported employment with a consulting company funded by Lilly. Five authors reported ties with various sources, including Lilly. Other authors declared no conflicts of interest.
Source: Joven B et al. Persistence and use of Ixekizumab in patients with psoriatic arthritis in real-world practice in Spain. The PRO-STIP Study. Rheumatol Ther. 2023 (Jul 23). doi: 10.1007/s40744-023-00584-8
Differential synovial and serum B-cell signatures between autoantibody-negative and autoantibody-positive RA
Key clinical point: Synovial and serum B-lymphocyte involvement differ between autoantibody-positive and autoantibody-negative rheumatoid arthritis (RA), with autoantibody-negative RA closely resembling that in polyarticular psoriatic arthritis (PsA).
Major finding: The CD20+ B-cell aggregational score was significantly lower in autoantibody-negative RA than in autoantibody-positive RA (mean 1.8 vs 2.4; P = .03) but comparable to that of polyarticular PsA (P = .78). The frequency of lympho-myeloid synovitis was lower in autoantibody-negative RA than in autoantibody-positive RA (38.2% vs 62.9%; P = .07) but comparable to that of polyarticular PsA (P = .8).
Study details: This study included 131 patients who underwent synovial biopsy and were categorized into those having autoantibody-positive RA (n = 43), autoantibody-negative RA (n = 35), symmetric polyarticular PsA (n = 25), and asymmetric oligoarticular PsA (n = 28).
Disclosures: This study was supported by IRCCS Policlinico San Matteo Foundation, Pavia, Italy. C Montecucco and S Bugatti reported receiving grants or research support and personal fees from various sources. The remaining authors declared no conflicts of interest.
Source: De Stefano L et al. Synovial and serum B-cell signature of autoantibody-negative rheumatoid arthritis versus autoantibody-positive rheumatoid arthritis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Jul 22). doi: 10.1093/rheumatology/kead378
Key clinical point: Synovial and serum B-lymphocyte involvement differ between autoantibody-positive and autoantibody-negative rheumatoid arthritis (RA), with autoantibody-negative RA closely resembling that in polyarticular psoriatic arthritis (PsA).
Major finding: The CD20+ B-cell aggregational score was significantly lower in autoantibody-negative RA than in autoantibody-positive RA (mean 1.8 vs 2.4; P = .03) but comparable to that of polyarticular PsA (P = .78). The frequency of lympho-myeloid synovitis was lower in autoantibody-negative RA than in autoantibody-positive RA (38.2% vs 62.9%; P = .07) but comparable to that of polyarticular PsA (P = .8).
Study details: This study included 131 patients who underwent synovial biopsy and were categorized into those having autoantibody-positive RA (n = 43), autoantibody-negative RA (n = 35), symmetric polyarticular PsA (n = 25), and asymmetric oligoarticular PsA (n = 28).
Disclosures: This study was supported by IRCCS Policlinico San Matteo Foundation, Pavia, Italy. C Montecucco and S Bugatti reported receiving grants or research support and personal fees from various sources. The remaining authors declared no conflicts of interest.
Source: De Stefano L et al. Synovial and serum B-cell signature of autoantibody-negative rheumatoid arthritis versus autoantibody-positive rheumatoid arthritis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Jul 22). doi: 10.1093/rheumatology/kead378
Key clinical point: Synovial and serum B-lymphocyte involvement differ between autoantibody-positive and autoantibody-negative rheumatoid arthritis (RA), with autoantibody-negative RA closely resembling that in polyarticular psoriatic arthritis (PsA).
Major finding: The CD20+ B-cell aggregational score was significantly lower in autoantibody-negative RA than in autoantibody-positive RA (mean 1.8 vs 2.4; P = .03) but comparable to that of polyarticular PsA (P = .78). The frequency of lympho-myeloid synovitis was lower in autoantibody-negative RA than in autoantibody-positive RA (38.2% vs 62.9%; P = .07) but comparable to that of polyarticular PsA (P = .8).
Study details: This study included 131 patients who underwent synovial biopsy and were categorized into those having autoantibody-positive RA (n = 43), autoantibody-negative RA (n = 35), symmetric polyarticular PsA (n = 25), and asymmetric oligoarticular PsA (n = 28).
Disclosures: This study was supported by IRCCS Policlinico San Matteo Foundation, Pavia, Italy. C Montecucco and S Bugatti reported receiving grants or research support and personal fees from various sources. The remaining authors declared no conflicts of interest.
Source: De Stefano L et al. Synovial and serum B-cell signature of autoantibody-negative rheumatoid arthritis versus autoantibody-positive rheumatoid arthritis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Jul 22). doi: 10.1093/rheumatology/kead378