The US Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor; Ipsen) for treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA or as monotherapy in patients unable to tolerate UDCA. 

PBC is a rare, chronic cholestatic liver disease that destroys interlobular bile ducts and leads to cholestasis and liver fibrosis. Left untreated, the disease can worsen over time, leading to cirrhosis and liver transplant and, in some cases, premature death. PBC also harms quality of life, with patients often experiencing severe fatigue and pruritus.

Iqirvo, an oral dual peroxisome proliferator–activated receptor (PPAR) alpha and delta agonist, is the first new drug approved in nearly a decade for treatment of PBC. 

Accelerated approval of Iqirvo for PBC was based on data from the phase 3 ELATIVE trial published last year in The New England Journal of Medicine. 

The trial randomly assigned patients with PBC who had an inadequate response to or unacceptable side effects with UDCA to receive either once-daily elafibranor (80 mg) or placebo. 

The primary endpoint was a biochemical response, defined as an alkaline phosphatase (ALP) level < 1.67 times the upper limit of the normal range, with a reduction ≥ 15% from baseline, as well as normal total bilirubin levels.

Among 161 patients, a biochemical response was seen in 55 of 108 (51%) who received elafibranor vs 2 of 53 (4%) who received placebo. 

At week 52, the ALP level normalized in 15% of patients in the elafibranor group and none of the patients in the placebo group.

In a news release announcing approval of Iqirvo, the company notes that improvement in survival and prevention of liver decompensation events have not been demonstrated and that continued approval for PBC may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common adverse effects with Iqirvo, reported in ≥ 10% of study participants, were weight gain, abdominal pain, diarrhea, nausea, and vomiting. Iqirvo is not recommended for people who have or develop decompensated cirrhosis. Full prescribing information is available online. 

The data show that Iqirvo is “an effective second-line treatment for patients with PBC with favorable benefit and risk data,” Kris Kowdley, MD, AGAF, director of the Liver Institute Northwest in Seattle, Washington, and a primary investigator on the ELATIVE study, said in the news release. 

The approval of Iqirvo “will allow healthcare providers in the US to address an unmet need with the potential to significantly reduce ALP levels for our patients with PBC,” Dr. Kowdley said.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor; Ipsen) for treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA or as monotherapy in patients unable to tolerate UDCA. 

PBC is a rare, chronic cholestatic liver disease that destroys interlobular bile ducts and leads to cholestasis and liver fibrosis. Left untreated, the disease can worsen over time, leading to cirrhosis and liver transplant and, in some cases, premature death. PBC also harms quality of life, with patients often experiencing severe fatigue and pruritus.

Iqirvo, an oral dual peroxisome proliferator–activated receptor (PPAR) alpha and delta agonist, is the first new drug approved in nearly a decade for treatment of PBC. 

Accelerated approval of Iqirvo for PBC was based on data from the phase 3 ELATIVE trial published last year in The New England Journal of Medicine. 

The trial randomly assigned patients with PBC who had an inadequate response to or unacceptable side effects with UDCA to receive either once-daily elafibranor (80 mg) or placebo. 

The primary endpoint was a biochemical response, defined as an alkaline phosphatase (ALP) level < 1.67 times the upper limit of the normal range, with a reduction ≥ 15% from baseline, as well as normal total bilirubin levels.

Among 161 patients, a biochemical response was seen in 55 of 108 (51%) who received elafibranor vs 2 of 53 (4%) who received placebo. 

At week 52, the ALP level normalized in 15% of patients in the elafibranor group and none of the patients in the placebo group.

In a news release announcing approval of Iqirvo, the company notes that improvement in survival and prevention of liver decompensation events have not been demonstrated and that continued approval for PBC may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common adverse effects with Iqirvo, reported in ≥ 10% of study participants, were weight gain, abdominal pain, diarrhea, nausea, and vomiting. Iqirvo is not recommended for people who have or develop decompensated cirrhosis. Full prescribing information is available online. 

The data show that Iqirvo is “an effective second-line treatment for patients with PBC with favorable benefit and risk data,” Kris Kowdley, MD, AGAF, director of the Liver Institute Northwest in Seattle, Washington, and a primary investigator on the ELATIVE study, said in the news release. 

The approval of Iqirvo “will allow healthcare providers in the US to address an unmet need with the potential to significantly reduce ALP levels for our patients with PBC,” Dr. Kowdley said.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor; Ipsen) for treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA or as monotherapy in patients unable to tolerate UDCA. 

PBC is a rare, chronic cholestatic liver disease that destroys interlobular bile ducts and leads to cholestasis and liver fibrosis. Left untreated, the disease can worsen over time, leading to cirrhosis and liver transplant and, in some cases, premature death. PBC also harms quality of life, with patients often experiencing severe fatigue and pruritus.

Iqirvo, an oral dual peroxisome proliferator–activated receptor (PPAR) alpha and delta agonist, is the first new drug approved in nearly a decade for treatment of PBC. 

Accelerated approval of Iqirvo for PBC was based on data from the phase 3 ELATIVE trial published last year in The New England Journal of Medicine. 

The trial randomly assigned patients with PBC who had an inadequate response to or unacceptable side effects with UDCA to receive either once-daily elafibranor (80 mg) or placebo. 

The primary endpoint was a biochemical response, defined as an alkaline phosphatase (ALP) level < 1.67 times the upper limit of the normal range, with a reduction ≥ 15% from baseline, as well as normal total bilirubin levels.

Among 161 patients, a biochemical response was seen in 55 of 108 (51%) who received elafibranor vs 2 of 53 (4%) who received placebo. 

At week 52, the ALP level normalized in 15% of patients in the elafibranor group and none of the patients in the placebo group.

In a news release announcing approval of Iqirvo, the company notes that improvement in survival and prevention of liver decompensation events have not been demonstrated and that continued approval for PBC may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common adverse effects with Iqirvo, reported in ≥ 10% of study participants, were weight gain, abdominal pain, diarrhea, nausea, and vomiting. Iqirvo is not recommended for people who have or develop decompensated cirrhosis. Full prescribing information is available online. 

The data show that Iqirvo is “an effective second-line treatment for patients with PBC with favorable benefit and risk data,” Kris Kowdley, MD, AGAF, director of the Liver Institute Northwest in Seattle, Washington, and a primary investigator on the ELATIVE study, said in the news release. 

The approval of Iqirvo “will allow healthcare providers in the US to address an unmet need with the potential to significantly reduce ALP levels for our patients with PBC,” Dr. Kowdley said.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 13% of older adults in the United States were treated for traumatic brain injury (TBI) over an 18-year period, a new study showed.

METHODOLOGY:

• Researchers analyzed data from approximately 9200 Medicare enrollees who were part of the Health and Retirement Study (HRS), aged 65 years and older, from 2000 to 2018.
• The baseline date was the date of the first age eligible HRS core interview in the community in 2000 or later.
• Incident TBI cases came from an updated list of the International Classification of Diseases (ICD), 9th and 10th edition codes, from the Defense and Veterans Brain Injury Center and the Armed Forces Health Surveillance Branch for TBI surveillance.
• Codes corresponded with emergency department, CT, and/or fMRI visits.

TAKEAWAY:

• Almost 13% of older individuals (n = 797) experienced TBI during the study, highlighting its significant prevalence in this population.
• Older adults (mean age at baseline, 75 years) who experienced TBI during the study period were more likely to be women and White individuals as well as individuals having higher levels of education and normal cognition (P < .001), challenging previous assumptions about risk factors.
• The study underscored the need for targeted interventions and research focused on TBI prevention and postdischarge care in older adults.

IN PRACTICE:

“The number of people 65 and older with TBI is shockingly high,” senior author Raquel Gardner, MD, said in a press release. “We need evidence-based guidelines to inform postdischarge care of this very large Medicare population and more research on post-TBI dementia prevention and repeat injury prevention.”

SOURCE:

The study was led by Erica Kornblith, PhD, of the University of California, San Francisco. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s reliance on ICD codes for TBI identification may not capture the full spectrum of TBI severity. Self-reported data on sociodemographic factors may have introduced bias, affecting the accuracy of associations with TBI incidence. In addition, the findings’ generalizability may be limited due to the study’s focus on Medicare enrollees, potentially excluding those from diverse socioeconomic backgrounds.

DISCLOSURES:

The study was funded by the Alzheimer’s Association, the US Department of Veterans Affairs, the National Institute on Aging, and the Department of Defense. Disclosures are noted in the original study.

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

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 13% of older adults in the United States were treated for traumatic brain injury (TBI) over an 18-year period, a new study showed.

METHODOLOGY:

• Researchers analyzed data from approximately 9200 Medicare enrollees who were part of the Health and Retirement Study (HRS), aged 65 years and older, from 2000 to 2018.
• The baseline date was the date of the first age eligible HRS core interview in the community in 2000 or later.
• Incident TBI cases came from an updated list of the International Classification of Diseases (ICD), 9th and 10th edition codes, from the Defense and Veterans Brain Injury Center and the Armed Forces Health Surveillance Branch for TBI surveillance.
• Codes corresponded with emergency department, CT, and/or fMRI visits.

TAKEAWAY:

• Almost 13% of older individuals (n = 797) experienced TBI during the study, highlighting its significant prevalence in this population.
• Older adults (mean age at baseline, 75 years) who experienced TBI during the study period were more likely to be women and White individuals as well as individuals having higher levels of education and normal cognition (P < .001), challenging previous assumptions about risk factors.
• The study underscored the need for targeted interventions and research focused on TBI prevention and postdischarge care in older adults.

IN PRACTICE:

“The number of people 65 and older with TBI is shockingly high,” senior author Raquel Gardner, MD, said in a press release. “We need evidence-based guidelines to inform postdischarge care of this very large Medicare population and more research on post-TBI dementia prevention and repeat injury prevention.”

SOURCE:

The study was led by Erica Kornblith, PhD, of the University of California, San Francisco. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s reliance on ICD codes for TBI identification may not capture the full spectrum of TBI severity. Self-reported data on sociodemographic factors may have introduced bias, affecting the accuracy of associations with TBI incidence. In addition, the findings’ generalizability may be limited due to the study’s focus on Medicare enrollees, potentially excluding those from diverse socioeconomic backgrounds.

DISCLOSURES:

The study was funded by the Alzheimer’s Association, the US Department of Veterans Affairs, the National Institute on Aging, and the Department of Defense. Disclosures are noted in the original study.

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

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 13% of older adults in the United States were treated for traumatic brain injury (TBI) over an 18-year period, a new study showed.

METHODOLOGY:

• Researchers analyzed data from approximately 9200 Medicare enrollees who were part of the Health and Retirement Study (HRS), aged 65 years and older, from 2000 to 2018.
• The baseline date was the date of the first age eligible HRS core interview in the community in 2000 or later.
• Incident TBI cases came from an updated list of the International Classification of Diseases (ICD), 9th and 10th edition codes, from the Defense and Veterans Brain Injury Center and the Armed Forces Health Surveillance Branch for TBI surveillance.
• Codes corresponded with emergency department, CT, and/or fMRI visits.

TAKEAWAY:

• Almost 13% of older individuals (n = 797) experienced TBI during the study, highlighting its significant prevalence in this population.
• Older adults (mean age at baseline, 75 years) who experienced TBI during the study period were more likely to be women and White individuals as well as individuals having higher levels of education and normal cognition (P < .001), challenging previous assumptions about risk factors.
• The study underscored the need for targeted interventions and research focused on TBI prevention and postdischarge care in older adults.

IN PRACTICE:

“The number of people 65 and older with TBI is shockingly high,” senior author Raquel Gardner, MD, said in a press release. “We need evidence-based guidelines to inform postdischarge care of this very large Medicare population and more research on post-TBI dementia prevention and repeat injury prevention.”

SOURCE:

The study was led by Erica Kornblith, PhD, of the University of California, San Francisco. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s reliance on ICD codes for TBI identification may not capture the full spectrum of TBI severity. Self-reported data on sociodemographic factors may have introduced bias, affecting the accuracy of associations with TBI incidence. In addition, the findings’ generalizability may be limited due to the study’s focus on Medicare enrollees, potentially excluding those from diverse socioeconomic backgrounds.

DISCLOSURES:

The study was funded by the Alzheimer’s Association, the US Department of Veterans Affairs, the National Institute on Aging, and the Department of Defense. Disclosures are noted in the original study.

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

A version of this article appeared on Medscape.com.

Key clinical point: The leptin/body mass index (BMI) ratio was higher in women with psoriatic arthritis (PsA) than in men with the disease and was also associated with pain intensity in women.

Major finding: The leptin/BMI ratio was significantly higher in women than in men (median 0.8 vs 0.2; P < .001). Pain intensity was associated with the leptin/BMI ratio in women (β 0.29; P < .004), while there was no significant association in men (P = .46).

Study details: This observational cross-sectional study included 203 patients with PsA aged 18 years or older, of whom 46.8% were women.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Toledano E, Gómez-Lechón L, Chacón CC, et al. Clinical features and disease activity in psoriatic arthritis: A sex-related perspective on leptin and comorbidity. J Clin Med. 2024;13(10):2959 (May 17). doi: 10.3390/jcm13102959 Source

Key clinical point: The leptin/body mass index (BMI) ratio was higher in women with psoriatic arthritis (PsA) than in men with the disease and was also associated with pain intensity in women.

Major finding: The leptin/BMI ratio was significantly higher in women than in men (median 0.8 vs 0.2; P < .001). Pain intensity was associated with the leptin/BMI ratio in women (β 0.29; P < .004), while there was no significant association in men (P = .46).

Study details: This observational cross-sectional study included 203 patients with PsA aged 18 years or older, of whom 46.8% were women.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Toledano E, Gómez-Lechón L, Chacón CC, et al. Clinical features and disease activity in psoriatic arthritis: A sex-related perspective on leptin and comorbidity. J Clin Med. 2024;13(10):2959 (May 17). doi: 10.3390/jcm13102959 Source

Key clinical point: The leptin/body mass index (BMI) ratio was higher in women with psoriatic arthritis (PsA) than in men with the disease and was also associated with pain intensity in women.

Major finding: The leptin/BMI ratio was significantly higher in women than in men (median 0.8 vs 0.2; P < .001). Pain intensity was associated with the leptin/BMI ratio in women (β 0.29; P < .004), while there was no significant association in men (P = .46).

Study details: This observational cross-sectional study included 203 patients with PsA aged 18 years or older, of whom 46.8% were women.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Toledano E, Gómez-Lechón L, Chacón CC, et al. Clinical features and disease activity in psoriatic arthritis: A sex-related perspective on leptin and comorbidity. J Clin Med. 2024;13(10):2959 (May 17). doi: 10.3390/jcm13102959 Source

Key clinical point: A real-world study showed that old age and initial radiographic damage were potential risk factors, while female sex was a protective factor, for radiographic progression in patients with early psoriatic arthritis (PsA).

Major finding: Female sex (incidence rate ratio [IRR] 0.48; P = .043) was a protective factor, while old age (IRR 1.10; P = .000) and initial radiographic damage (IRR 1.11; P = .000) were risk factors for development of radiographic progression over time. Initial Disease Activity in Psoriatic Arthritis (IRR 1.05; P = .006) and swollen joint count (IRR 1.07; P = .034) could predict radiographic changes in the subgroup of patients with existing progressive damage.

Study details: This study analyzed data from the Dutch South West Psoriatic Arthritis cohort including 476 patients with early PsA of whom 14% demonstrated progressive radiographic damage.

Disclosures: This study was sponsored by an unrestricted grant from Janssen. The authors did not declare any conflicts of interest.

Source: Koc GH, Kok MR, do Rosario Y, et al. Determinants of radiographic progression in early psoriatic arthritis: Insights from a real-world cohort. RMD Open. 2024; 10(2):e004080 (may 24). doi: 10.1136/rmdopen-2024-004080 Source

Key clinical point: A real-world study showed that old age and initial radiographic damage were potential risk factors, while female sex was a protective factor, for radiographic progression in patients with early psoriatic arthritis (PsA).

Major finding: Female sex (incidence rate ratio [IRR] 0.48; P = .043) was a protective factor, while old age (IRR 1.10; P = .000) and initial radiographic damage (IRR 1.11; P = .000) were risk factors for development of radiographic progression over time. Initial Disease Activity in Psoriatic Arthritis (IRR 1.05; P = .006) and swollen joint count (IRR 1.07; P = .034) could predict radiographic changes in the subgroup of patients with existing progressive damage.

Study details: This study analyzed data from the Dutch South West Psoriatic Arthritis cohort including 476 patients with early PsA of whom 14% demonstrated progressive radiographic damage.

Disclosures: This study was sponsored by an unrestricted grant from Janssen. The authors did not declare any conflicts of interest.

Source: Koc GH, Kok MR, do Rosario Y, et al. Determinants of radiographic progression in early psoriatic arthritis: Insights from a real-world cohort. RMD Open. 2024; 10(2):e004080 (may 24). doi: 10.1136/rmdopen-2024-004080 Source

Key clinical point: A real-world study showed that old age and initial radiographic damage were potential risk factors, while female sex was a protective factor, for radiographic progression in patients with early psoriatic arthritis (PsA).

Major finding: Female sex (incidence rate ratio [IRR] 0.48; P = .043) was a protective factor, while old age (IRR 1.10; P = .000) and initial radiographic damage (IRR 1.11; P = .000) were risk factors for development of radiographic progression over time. Initial Disease Activity in Psoriatic Arthritis (IRR 1.05; P = .006) and swollen joint count (IRR 1.07; P = .034) could predict radiographic changes in the subgroup of patients with existing progressive damage.

Study details: This study analyzed data from the Dutch South West Psoriatic Arthritis cohort including 476 patients with early PsA of whom 14% demonstrated progressive radiographic damage.

Disclosures: This study was sponsored by an unrestricted grant from Janssen. The authors did not declare any conflicts of interest.

Source: Koc GH, Kok MR, do Rosario Y, et al. Determinants of radiographic progression in early psoriatic arthritis: Insights from a real-world cohort. RMD Open. 2024; 10(2):e004080 (may 24). doi: 10.1136/rmdopen-2024-004080 Source

Key clinical point: Fibromyalgia and widespread pain were prevalent and associated with elevated disease activity in patients with psoriatic arthritis (PsA).

Major finding: Fibromyalgia and widespread pain were present in 11.1% and 20.6% of patients, respectively. The scores for Clinical Disease Activity in Psoriatic Arthritis were elevated in patients with vs without fibromyalgia (mean difference [Δ] 13.02; 95% CI 10.42-15.63) and in those with vs without widespread pain (Δ 11.94; 95% CI 9.96-13.92). Fibromyalgia was more prevalent in women (P < .001), patients with increased BMI (P = .002), patients diagnosed with spondyloarthritis (P = .005), and patients with a history of cardiovascular diseases (P = .004) and diabetes (P = .007).

Study details: This cross-sectional study included 1823 patients with PsA (age ≥ 18 years) from the CorEvitas US registry.

Disclosures: This study was funded and supported by the Corrona Research Foundation. The data is licensed to the Corrona Research Foundation by CorEvitas, LLC. All authors declared receiving consulting fees or grants from CorEvitas, LLC; Corrona Research Foundation; and other sources.

Source: Mease P, Reed G, Ogdie A, et al. Prevalence of fibromyalgia and widespread pain in psoriatic arthritis: Association with disease severity assessment in a large US registry. Arthritis Care Res (Hoboken). 2024 (May 12). doi: 10.1002/acr.25358 Source

Key clinical point: Fibromyalgia and widespread pain were prevalent and associated with elevated disease activity in patients with psoriatic arthritis (PsA).

Major finding: Fibromyalgia and widespread pain were present in 11.1% and 20.6% of patients, respectively. The scores for Clinical Disease Activity in Psoriatic Arthritis were elevated in patients with vs without fibromyalgia (mean difference [Δ] 13.02; 95% CI 10.42-15.63) and in those with vs without widespread pain (Δ 11.94; 95% CI 9.96-13.92). Fibromyalgia was more prevalent in women (P < .001), patients with increased BMI (P = .002), patients diagnosed with spondyloarthritis (P = .005), and patients with a history of cardiovascular diseases (P = .004) and diabetes (P = .007).

Study details: This cross-sectional study included 1823 patients with PsA (age ≥ 18 years) from the CorEvitas US registry.

Disclosures: This study was funded and supported by the Corrona Research Foundation. The data is licensed to the Corrona Research Foundation by CorEvitas, LLC. All authors declared receiving consulting fees or grants from CorEvitas, LLC; Corrona Research Foundation; and other sources.

Source: Mease P, Reed G, Ogdie A, et al. Prevalence of fibromyalgia and widespread pain in psoriatic arthritis: Association with disease severity assessment in a large US registry. Arthritis Care Res (Hoboken). 2024 (May 12). doi: 10.1002/acr.25358 Source

Key clinical point: Fibromyalgia and widespread pain were prevalent and associated with elevated disease activity in patients with psoriatic arthritis (PsA).

Major finding: Fibromyalgia and widespread pain were present in 11.1% and 20.6% of patients, respectively. The scores for Clinical Disease Activity in Psoriatic Arthritis were elevated in patients with vs without fibromyalgia (mean difference [Δ] 13.02; 95% CI 10.42-15.63) and in those with vs without widespread pain (Δ 11.94; 95% CI 9.96-13.92). Fibromyalgia was more prevalent in women (P < .001), patients with increased BMI (P = .002), patients diagnosed with spondyloarthritis (P = .005), and patients with a history of cardiovascular diseases (P = .004) and diabetes (P = .007).

Study details: This cross-sectional study included 1823 patients with PsA (age ≥ 18 years) from the CorEvitas US registry.

Disclosures: This study was funded and supported by the Corrona Research Foundation. The data is licensed to the Corrona Research Foundation by CorEvitas, LLC. All authors declared receiving consulting fees or grants from CorEvitas, LLC; Corrona Research Foundation; and other sources.

Source: Mease P, Reed G, Ogdie A, et al. Prevalence of fibromyalgia and widespread pain in psoriatic arthritis: Association with disease severity assessment in a large US registry. Arthritis Care Res (Hoboken). 2024 (May 12). doi: 10.1002/acr.25358 Source

Key clinical point: Aortic stiffness was significantly higher in individuals with vs without psoriatic arthritis (PsA), and a longer disease duration was a predictor of increased aortic stiffness in the PsA population.

Major finding: Aortic stiffness, measured by carotid femoral pulse wave velocity, was significantly higher in patients with PsA than in healthy individuals without systemic inflammatory disease (7.80 vs 6.76 m/s; regression coefficient [β] 0.457; P_adj = .034). Aortic stiffness was positively associated with disease duration (β 0.028; P_adj = .020), red cell distribution width (Pearson correlation coefficient 0.190; P = .020), and systolic blood pressure (Spearman correlation coefficient [ρ] 0.351; P < .001), and inversely associated with glomerular filtration rate (ρ −0.264; P = .001).

Study details: This prospective PSOriatic Arthritis CARDiovascular Disease cohort included 150 patients with PsA and 88 healthy individuals without systemic inflammatory disease.

Disclosures: This study did not receive any specific funding. One author declared being an editorial board member of Rheumatology and Therapy. Other authors declared no conflicts of interest.

Source: Triantafyllias K, Liverakos S, Muthuraman M, et al. Cardiovascular risk evaluation in psoriatic arthritis by aortic stiffness and the Systemic Coronary Risk Evaluation (SCORE): Results of the prospective PSOCARD cohort study. Rheumatol Ther. 2024 (May 31). doi: 10.1007/s40744-024-00676-z Source

Key clinical point: Aortic stiffness was significantly higher in individuals with vs without psoriatic arthritis (PsA), and a longer disease duration was a predictor of increased aortic stiffness in the PsA population.

Major finding: Aortic stiffness, measured by carotid femoral pulse wave velocity, was significantly higher in patients with PsA than in healthy individuals without systemic inflammatory disease (7.80 vs 6.76 m/s; regression coefficient [β] 0.457; P_adj = .034). Aortic stiffness was positively associated with disease duration (β 0.028; P_adj = .020), red cell distribution width (Pearson correlation coefficient 0.190; P = .020), and systolic blood pressure (Spearman correlation coefficient [ρ] 0.351; P < .001), and inversely associated with glomerular filtration rate (ρ −0.264; P = .001).

Study details: This prospective PSOriatic Arthritis CARDiovascular Disease cohort included 150 patients with PsA and 88 healthy individuals without systemic inflammatory disease.

Disclosures: This study did not receive any specific funding. One author declared being an editorial board member of Rheumatology and Therapy. Other authors declared no conflicts of interest.

Source: Triantafyllias K, Liverakos S, Muthuraman M, et al. Cardiovascular risk evaluation in psoriatic arthritis by aortic stiffness and the Systemic Coronary Risk Evaluation (SCORE): Results of the prospective PSOCARD cohort study. Rheumatol Ther. 2024 (May 31). doi: 10.1007/s40744-024-00676-z Source

Key clinical point: Aortic stiffness was significantly higher in individuals with vs without psoriatic arthritis (PsA), and a longer disease duration was a predictor of increased aortic stiffness in the PsA population.

Major finding: Aortic stiffness, measured by carotid femoral pulse wave velocity, was significantly higher in patients with PsA than in healthy individuals without systemic inflammatory disease (7.80 vs 6.76 m/s; regression coefficient [β] 0.457; P_adj = .034). Aortic stiffness was positively associated with disease duration (β 0.028; P_adj = .020), red cell distribution width (Pearson correlation coefficient 0.190; P = .020), and systolic blood pressure (Spearman correlation coefficient [ρ] 0.351; P < .001), and inversely associated with glomerular filtration rate (ρ −0.264; P = .001).

Study details: This prospective PSOriatic Arthritis CARDiovascular Disease cohort included 150 patients with PsA and 88 healthy individuals without systemic inflammatory disease.

Disclosures: This study did not receive any specific funding. One author declared being an editorial board member of Rheumatology and Therapy. Other authors declared no conflicts of interest.

Source: Triantafyllias K, Liverakos S, Muthuraman M, et al. Cardiovascular risk evaluation in psoriatic arthritis by aortic stiffness and the Systemic Coronary Risk Evaluation (SCORE): Results of the prospective PSOCARD cohort study. Rheumatol Ther. 2024 (May 31). doi: 10.1007/s40744-024-00676-z Source

Key clinical point: Treatment with biologics significantly reduced the risk for psoriatic arthritis (PsA) development, including peripheral and axial PsA development, in patients with psoriasis.

Major finding: Patients treated at least once vs never treated with biologics had a significantly lower risk for PsA (8.9% vs 26.1%; adjusted odds ratio [aOR] 0.228; P < .001), including for peripheral PsA (aOR 0.182; P < .001) and peripheral PsA with axial involvement (aOR 0.115; P = .039). The protective effect of biologics against PsA persisted irrespective of the class of biologic used.

Study details: Findings are from an analysis of a cohort study that included 1023 patients with psoriasis aged 18 years or older, of whom 29.6% received biologics at least once and 21.0% had PsA.

Disclosures: This study did not receive any specific funding. Four authors declared receiving consulting or speaking fees or having other ties from various sources. Other authors declared no conflicts of interest.

Source: Floris A, Mugheddu C, Sichi L, et al. Treatment of psoriasis with different classes of biologics reduces the likelihood of peripheral and axial psoriatic arthritis development. Rheumatology (Oxford). 2024 (May 23). doi: 10.1093/rheumatology/keae257 Source

Key clinical point: Treatment with biologics significantly reduced the risk for psoriatic arthritis (PsA) development, including peripheral and axial PsA development, in patients with psoriasis.

Major finding: Patients treated at least once vs never treated with biologics had a significantly lower risk for PsA (8.9% vs 26.1%; adjusted odds ratio [aOR] 0.228; P < .001), including for peripheral PsA (aOR 0.182; P < .001) and peripheral PsA with axial involvement (aOR 0.115; P = .039). The protective effect of biologics against PsA persisted irrespective of the class of biologic used.

Study details: Findings are from an analysis of a cohort study that included 1023 patients with psoriasis aged 18 years or older, of whom 29.6% received biologics at least once and 21.0% had PsA.

Disclosures: This study did not receive any specific funding. Four authors declared receiving consulting or speaking fees or having other ties from various sources. Other authors declared no conflicts of interest.

Source: Floris A, Mugheddu C, Sichi L, et al. Treatment of psoriasis with different classes of biologics reduces the likelihood of peripheral and axial psoriatic arthritis development. Rheumatology (Oxford). 2024 (May 23). doi: 10.1093/rheumatology/keae257 Source

Key clinical point: Treatment with biologics significantly reduced the risk for psoriatic arthritis (PsA) development, including peripheral and axial PsA development, in patients with psoriasis.

Major finding: Patients treated at least once vs never treated with biologics had a significantly lower risk for PsA (8.9% vs 26.1%; adjusted odds ratio [aOR] 0.228; P < .001), including for peripheral PsA (aOR 0.182; P < .001) and peripheral PsA with axial involvement (aOR 0.115; P = .039). The protective effect of biologics against PsA persisted irrespective of the class of biologic used.

Study details: Findings are from an analysis of a cohort study that included 1023 patients with psoriasis aged 18 years or older, of whom 29.6% received biologics at least once and 21.0% had PsA.

Disclosures: This study did not receive any specific funding. Four authors declared receiving consulting or speaking fees or having other ties from various sources. Other authors declared no conflicts of interest.

Source: Floris A, Mugheddu C, Sichi L, et al. Treatment of psoriasis with different classes of biologics reduces the likelihood of peripheral and axial psoriatic arthritis development. Rheumatology (Oxford). 2024 (May 23). doi: 10.1093/rheumatology/keae257 Source

Key clinical point: A dose of 80 mg ixekizumab every 2 (Q2W) or 4 (Q4W) weeks demonstrated rapid and consistent efficacy, regardless of the extent of initial skin involvement in patients with psoriatic arthritis (PsA).

Major finding: In both ixekizumab treatment arms (Q2W and Q4W), over one-third of patients achieved ≥20% improvement in American College of Rheumatology (ACR)20 response as early as week 4, with the number increasing to approximately half at week 24. A similar proportion of patients achieved ACR20/50/70 response at week 24 irrespective of initial psoriasis severity (P > .05).

Study details: This post hoc subgroup analysis of SPIRIT-P1 and SPIRIT-P2 included 655 patients with active PsA and plaque psoriasis who were randomly assigned to receive placebo or 80 mg ixekizumab Q2W or Q4W.

Disclosures: The sponsorship and Rapid Service Fee for this study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. Several authors declared receiving grants or honoraria or having other ties with various sources, including Eli Lilly and Company.

Source: Armstrong AW, Jaleel T, Merola JF, et al. Ixekizumab demonstrates rapid and consistent efficacy for patients with psoriatic arthritis, regardless of psoriasis severity. Dermatol Ther (Heidelb). 2024;14:1615-1631 (May 30). Source

Key clinical point: A dose of 80 mg ixekizumab every 2 (Q2W) or 4 (Q4W) weeks demonstrated rapid and consistent efficacy, regardless of the extent of initial skin involvement in patients with psoriatic arthritis (PsA).

Major finding: In both ixekizumab treatment arms (Q2W and Q4W), over one-third of patients achieved ≥20% improvement in American College of Rheumatology (ACR)20 response as early as week 4, with the number increasing to approximately half at week 24. A similar proportion of patients achieved ACR20/50/70 response at week 24 irrespective of initial psoriasis severity (P > .05).

Study details: This post hoc subgroup analysis of SPIRIT-P1 and SPIRIT-P2 included 655 patients with active PsA and plaque psoriasis who were randomly assigned to receive placebo or 80 mg ixekizumab Q2W or Q4W.

Disclosures: The sponsorship and Rapid Service Fee for this study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. Several authors declared receiving grants or honoraria or having other ties with various sources, including Eli Lilly and Company.

Source: Armstrong AW, Jaleel T, Merola JF, et al. Ixekizumab demonstrates rapid and consistent efficacy for patients with psoriatic arthritis, regardless of psoriasis severity. Dermatol Ther (Heidelb). 2024;14:1615-1631 (May 30). Source

Key clinical point: A dose of 80 mg ixekizumab every 2 (Q2W) or 4 (Q4W) weeks demonstrated rapid and consistent efficacy, regardless of the extent of initial skin involvement in patients with psoriatic arthritis (PsA).

Major finding: In both ixekizumab treatment arms (Q2W and Q4W), over one-third of patients achieved ≥20% improvement in American College of Rheumatology (ACR)20 response as early as week 4, with the number increasing to approximately half at week 24. A similar proportion of patients achieved ACR20/50/70 response at week 24 irrespective of initial psoriasis severity (P > .05).

Study details: This post hoc subgroup analysis of SPIRIT-P1 and SPIRIT-P2 included 655 patients with active PsA and plaque psoriasis who were randomly assigned to receive placebo or 80 mg ixekizumab Q2W or Q4W.

Disclosures: The sponsorship and Rapid Service Fee for this study was funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly. Several authors declared receiving grants or honoraria or having other ties with various sources, including Eli Lilly and Company.

Source: Armstrong AW, Jaleel T, Merola JF, et al. Ixekizumab demonstrates rapid and consistent efficacy for patients with psoriatic arthritis, regardless of psoriasis severity. Dermatol Ther (Heidelb). 2024;14:1615-1631 (May 30). Source

Key clinical point: Bimekizumab improved disease impact in a rapid and sustained manner in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD-naive) or had prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: A numerically higher proportion of bDMARD-naive patients receiving bimekizumab vs placebo achieved a clinically meaningful improvement in disease impact at week 4 (20.3% vs 2.5%) and 16 (36.8% vs 10.1%). These improvements were sustained till week 52 in patients who received bimekizumab continuously (49.0%) and in those who switched from placebo to bimekizumab (44.4%). Results were similar in the TNFi-IR subgroup.

Study details: Findings are from two phase 3 studies including 1112 patients with PsA who were bDMARD-naive or TNFi-IR and were randomly assigned to receive 160 mg bimekizumab every 4 weeks (n = 698) or placebo with crossover to bimekizumab at week 16 (n = 414).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees or shareholders of UCB Pharma. Other authors declared various ties with various sources, including UCB Pharma.

Source: Gossec L, Orbai AM, de Wit M, et al. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 (May 16). doi: 10.1093/rheumatology/keae277 Source

Key clinical point: Bimekizumab improved disease impact in a rapid and sustained manner in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD-naive) or had prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: A numerically higher proportion of bDMARD-naive patients receiving bimekizumab vs placebo achieved a clinically meaningful improvement in disease impact at week 4 (20.3% vs 2.5%) and 16 (36.8% vs 10.1%). These improvements were sustained till week 52 in patients who received bimekizumab continuously (49.0%) and in those who switched from placebo to bimekizumab (44.4%). Results were similar in the TNFi-IR subgroup.

Study details: Findings are from two phase 3 studies including 1112 patients with PsA who were bDMARD-naive or TNFi-IR and were randomly assigned to receive 160 mg bimekizumab every 4 weeks (n = 698) or placebo with crossover to bimekizumab at week 16 (n = 414).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees or shareholders of UCB Pharma. Other authors declared various ties with various sources, including UCB Pharma.

Source: Gossec L, Orbai AM, de Wit M, et al. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 (May 16). doi: 10.1093/rheumatology/keae277 Source

Key clinical point: Bimekizumab improved disease impact in a rapid and sustained manner in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD-naive) or had prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: A numerically higher proportion of bDMARD-naive patients receiving bimekizumab vs placebo achieved a clinically meaningful improvement in disease impact at week 4 (20.3% vs 2.5%) and 16 (36.8% vs 10.1%). These improvements were sustained till week 52 in patients who received bimekizumab continuously (49.0%) and in those who switched from placebo to bimekizumab (44.4%). Results were similar in the TNFi-IR subgroup.

Study details: Findings are from two phase 3 studies including 1112 patients with PsA who were bDMARD-naive or TNFi-IR and were randomly assigned to receive 160 mg bimekizumab every 4 weeks (n = 698) or placebo with crossover to bimekizumab at week 16 (n = 414).

Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees or shareholders of UCB Pharma. Other authors declared various ties with various sources, including UCB Pharma.

Source: Gossec L, Orbai AM, de Wit M, et al. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 (May 16). doi: 10.1093/rheumatology/keae277 Source

Key clinical point: Risankizumab vs placebo led to higher resolution rates for enthesitis and dactylitis at 24 weeks in patients with active psoriatic arthritis (PsA), which were sustained through 52 weeks.

Major finding: At week 24, a higher proportion of risankizumab- vs placebo-treated patients achieved resolution of enthesitis (48.4% vs 34.8%; P < .001), dactylitis (68.1% vs 51.0%; P < .001), and enthesitis + dactylitis (42.2% vs 28.6%; P < .05). More than 50% of patients who continuously received risankizumab or switched from placebo to risankizumab at week 24 achieved resolution of enthesitis, dactylitis, or both.

Study details: This integrated post hoc analysis of the KEEPsAKE 1 and KEEPsAKE 2 trials included 1407 patients with PsA and previous inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stocks, stock options, or patents of AbbVie. Five authors declared ties with various sources, including AbbVie.

Source: Kwatra SG, Khattri S, Amin AZ, et al. Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 trials. Dermatol Ther (Heidelb). 2024;14:1517-1530 (May 13). doi: 10.1007/s13555-024-01174-4 Source

Key clinical point: Risankizumab vs placebo led to higher resolution rates for enthesitis and dactylitis at 24 weeks in patients with active psoriatic arthritis (PsA), which were sustained through 52 weeks.

Major finding: At week 24, a higher proportion of risankizumab- vs placebo-treated patients achieved resolution of enthesitis (48.4% vs 34.8%; P < .001), dactylitis (68.1% vs 51.0%; P < .001), and enthesitis + dactylitis (42.2% vs 28.6%; P < .05). More than 50% of patients who continuously received risankizumab or switched from placebo to risankizumab at week 24 achieved resolution of enthesitis, dactylitis, or both.

Study details: This integrated post hoc analysis of the KEEPsAKE 1 and KEEPsAKE 2 trials included 1407 patients with PsA and previous inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stocks, stock options, or patents of AbbVie. Five authors declared ties with various sources, including AbbVie.

Source: Kwatra SG, Khattri S, Amin AZ, et al. Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 trials. Dermatol Ther (Heidelb). 2024;14:1517-1530 (May 13). doi: 10.1007/s13555-024-01174-4 Source

Key clinical point: Risankizumab vs placebo led to higher resolution rates for enthesitis and dactylitis at 24 weeks in patients with active psoriatic arthritis (PsA), which were sustained through 52 weeks.

Major finding: At week 24, a higher proportion of risankizumab- vs placebo-treated patients achieved resolution of enthesitis (48.4% vs 34.8%; P < .001), dactylitis (68.1% vs 51.0%; P < .001), and enthesitis + dactylitis (42.2% vs 28.6%; P < .05). More than 50% of patients who continuously received risankizumab or switched from placebo to risankizumab at week 24 achieved resolution of enthesitis, dactylitis, or both.

Study details: This integrated post hoc analysis of the KEEPsAKE 1 and KEEPsAKE 2 trials included 1407 patients with PsA and previous inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or holding stocks, stock options, or patents of AbbVie. Five authors declared ties with various sources, including AbbVie.

Source: Kwatra SG, Khattri S, Amin AZ, et al. Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 trials. Dermatol Ther (Heidelb). 2024;14:1517-1530 (May 13). doi: 10.1007/s13555-024-01174-4 Source