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Achievement of low disease activity improves long-term structural damage in PsA
Key clinical point: Achievement of low or minimal disease activity levels with guselkumab therapy diminished radiographic progression over 2 years in patients with psoriatic arthritis (PsA) at risk for radiographic damage.
Major finding: Among patients receiving guselkumab, the mean change in total van der Heijde-Sharp score from 0 to 100 weeks was numerically lower among those who achieved clinical response at week 52 vs non-responders, as assessed by ≥20% improvement in American College of Rheumatology criteria (1.0-1.2 vs 2.8-4.1), PsA Disease Activity Score low disease activity (LDA; 1.0 vs 1.9-2.4), and Disease Activity in PsA LDA (0.7-0.9 vs 2.3-3.1).
Study details: The data come from a post hoc analysis of the DISCOVER-2 study including 664 biologic-naïve patients with PsA who received guselkumab or placebo.
Disclosures: This study was funded by the Janssen Research & Development, LLC. Some authors reported ties with various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks in Johnson & Johnson.
Source: Gottlieb AB et al. Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: Results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis. RMD Open. 2023;9:e002789 (Feb 24). Doi: 10.1136/rmdopen-2022-002789
Key clinical point: Achievement of low or minimal disease activity levels with guselkumab therapy diminished radiographic progression over 2 years in patients with psoriatic arthritis (PsA) at risk for radiographic damage.
Major finding: Among patients receiving guselkumab, the mean change in total van der Heijde-Sharp score from 0 to 100 weeks was numerically lower among those who achieved clinical response at week 52 vs non-responders, as assessed by ≥20% improvement in American College of Rheumatology criteria (1.0-1.2 vs 2.8-4.1), PsA Disease Activity Score low disease activity (LDA; 1.0 vs 1.9-2.4), and Disease Activity in PsA LDA (0.7-0.9 vs 2.3-3.1).
Study details: The data come from a post hoc analysis of the DISCOVER-2 study including 664 biologic-naïve patients with PsA who received guselkumab or placebo.
Disclosures: This study was funded by the Janssen Research & Development, LLC. Some authors reported ties with various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks in Johnson & Johnson.
Source: Gottlieb AB et al. Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: Results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis. RMD Open. 2023;9:e002789 (Feb 24). Doi: 10.1136/rmdopen-2022-002789
Key clinical point: Achievement of low or minimal disease activity levels with guselkumab therapy diminished radiographic progression over 2 years in patients with psoriatic arthritis (PsA) at risk for radiographic damage.
Major finding: Among patients receiving guselkumab, the mean change in total van der Heijde-Sharp score from 0 to 100 weeks was numerically lower among those who achieved clinical response at week 52 vs non-responders, as assessed by ≥20% improvement in American College of Rheumatology criteria (1.0-1.2 vs 2.8-4.1), PsA Disease Activity Score low disease activity (LDA; 1.0 vs 1.9-2.4), and Disease Activity in PsA LDA (0.7-0.9 vs 2.3-3.1).
Study details: The data come from a post hoc analysis of the DISCOVER-2 study including 664 biologic-naïve patients with PsA who received guselkumab or placebo.
Disclosures: This study was funded by the Janssen Research & Development, LLC. Some authors reported ties with various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks in Johnson & Johnson.
Source: Gottlieb AB et al. Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: Results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis. RMD Open. 2023;9:e002789 (Feb 24). Doi: 10.1136/rmdopen-2022-002789
Gender-based differences in treatment outcomes and persistence with ustekinumab or TNFi in PsA
Key clinical point: Ustekinumab or tumor necrosis factor inhibitor (TNFi) improved outcomes in patients with psoriatic arthritis (PsA); however, women vs men with PsA were in a worse disease state, with a greater proportion stopping or switching biologics.
Major finding: At 12 months, minimal disease activity including very low disease activity (LDA) and Clinical Disease Activity Index for PsA LDA (including remission) were achieved by 33.7% vs 55.5% and 57.8% vs 80.3% of women vs men, respectively. Men vs women demonstrated higher treatment persistence (P ≤ .001), with 12.5% vs 22.1% discontinuing treatment, respectively.
Study details: This post hoc analysis of the prospective real-world PsABio study included 895 patients with PsA (men: n = 400; womwn: n = 495) who initiated ustekinumab or TNFi.
Disclosures: This study was sponsored by Janssen. The authors reported serving as consultants or on speaker’s bureaus or receiving grants from various sources, including Janssen. Some authors declared being current or former employees of Janssen or shareholders of Johnson & Johnson.
Source: Van Kuijk AWR et al. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: Real-world data. Rheumatology (Oxford). 2023 (Feb 22). Doi: 10.1093/rheumatology/kead089
Key clinical point: Ustekinumab or tumor necrosis factor inhibitor (TNFi) improved outcomes in patients with psoriatic arthritis (PsA); however, women vs men with PsA were in a worse disease state, with a greater proportion stopping or switching biologics.
Major finding: At 12 months, minimal disease activity including very low disease activity (LDA) and Clinical Disease Activity Index for PsA LDA (including remission) were achieved by 33.7% vs 55.5% and 57.8% vs 80.3% of women vs men, respectively. Men vs women demonstrated higher treatment persistence (P ≤ .001), with 12.5% vs 22.1% discontinuing treatment, respectively.
Study details: This post hoc analysis of the prospective real-world PsABio study included 895 patients with PsA (men: n = 400; womwn: n = 495) who initiated ustekinumab or TNFi.
Disclosures: This study was sponsored by Janssen. The authors reported serving as consultants or on speaker’s bureaus or receiving grants from various sources, including Janssen. Some authors declared being current or former employees of Janssen or shareholders of Johnson & Johnson.
Source: Van Kuijk AWR et al. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: Real-world data. Rheumatology (Oxford). 2023 (Feb 22). Doi: 10.1093/rheumatology/kead089
Key clinical point: Ustekinumab or tumor necrosis factor inhibitor (TNFi) improved outcomes in patients with psoriatic arthritis (PsA); however, women vs men with PsA were in a worse disease state, with a greater proportion stopping or switching biologics.
Major finding: At 12 months, minimal disease activity including very low disease activity (LDA) and Clinical Disease Activity Index for PsA LDA (including remission) were achieved by 33.7% vs 55.5% and 57.8% vs 80.3% of women vs men, respectively. Men vs women demonstrated higher treatment persistence (P ≤ .001), with 12.5% vs 22.1% discontinuing treatment, respectively.
Study details: This post hoc analysis of the prospective real-world PsABio study included 895 patients with PsA (men: n = 400; womwn: n = 495) who initiated ustekinumab or TNFi.
Disclosures: This study was sponsored by Janssen. The authors reported serving as consultants or on speaker’s bureaus or receiving grants from various sources, including Janssen. Some authors declared being current or former employees of Janssen or shareholders of Johnson & Johnson.
Source: Van Kuijk AWR et al. Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: Real-world data. Rheumatology (Oxford). 2023 (Feb 22). Doi: 10.1093/rheumatology/kead089
Psoriatic arthritis treatment for women falls short, study suggests
Women with psoriatic arthritis (PsA) presented with more severe disease at baseline and were less likely to achieve favorable outcomes after 12 months of treatment with either ustekinumab (Stelara) or a tumor necrosis factor (TNF) inhibitor, compared with men, according to a post hoc analysis of data from nearly 1,000 individuals.
Although data suggest that the overall prevalence of PsA is similar across genders, recent studies have identified differences in various aspects of PsA between men and women, wrote Arno W.R. Van Kuijk, MD, of Amsterdam Rheumatology and Immunology Center, and colleagues wrote in a study published in Rheumatology.
“Accumulating evidence in multiple rheumatic diseases indicates that gender may influence the likelihood of achieving the desired outcome with treatment,” but studies of differences in treatment response according to gender are limited, they said.
The researchers conducted a post hoc analysis of women and men with PsA who were part of PsABio, a noninterventional European study of patients with PsA. All participants were starting first-, second-, or third-line treatment with ustekinumab or a TNF inhibitor. The primary outcome was response to treatment at 12 months. Disease activity was assessed using the clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), the Health Assessment Questionnaire–Disability Index (HAQ-DI), and total score on the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire.
Baseline available data for 512 women and 417 men showed the mean duration of disease was similar between genders (6.7 years for females and 6.9 years for males); body mass index was similar, as was the proportion of male and female patients receiving concomitant conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Females scored significantly worse than males on disease activity assessments at baseline with mean cDAPSA scores of 32.3 and 26.8, respectively.
The final analysis of 895 patients with baseline data and a postbaseline assessment included 439 who started ustekinumab (247 females, 192 males), and 456 who started a TNF inhibitor (248 females, 208 males).
At 12 months, females showed smaller degrees of improvement than males; 57.8% and 80.3%, respectively, achieved low disease activity based on cDAPSA scores, while 33.7% and 55.5% of females and males, respectively, achieved minimal disease activity. Measures of disability were higher in females than males, with HAQ-DI scores of 0.85 versus 0.50. PsAID-12 scores also were higher for females, compared with males (3.5 vs. 2.4).
A total of 81.7% of patients were on their initial biologic DMARD after 12 months, but more females than males who were taking ustekinumab or a TNF inhibitor changed or discontinued treatment.
Treatment persistence was significantly lower in females than males (P = .01), and lack of effectiveness was the main reason for discontinuation regardless of gender.
“The analysis of gender subgroup results of the PsABio study has expanded previously published observations that men and women with PsA have different experiences with the disease activity, clinical manifestations, impact on health-related quality of life, response to [biologic] DMARDs, and drug persistence,” the researchers wrote.
The lack of a medication protocol in the PsABio study limited the conclusions that could be drawn from the post hoc analysis, but the results were strengthened by the relatively large and diverse sample size and the inclusion of responses to more than one medication, the researchers noted.
The study was supported by Janssen. Dr. Van Kuijk disclosed serving as a consultant and receiving grant support from Janssen and other companies; several coauthors also disclosed relationships with Janssen.
Women with psoriatic arthritis (PsA) presented with more severe disease at baseline and were less likely to achieve favorable outcomes after 12 months of treatment with either ustekinumab (Stelara) or a tumor necrosis factor (TNF) inhibitor, compared with men, according to a post hoc analysis of data from nearly 1,000 individuals.
Although data suggest that the overall prevalence of PsA is similar across genders, recent studies have identified differences in various aspects of PsA between men and women, wrote Arno W.R. Van Kuijk, MD, of Amsterdam Rheumatology and Immunology Center, and colleagues wrote in a study published in Rheumatology.
“Accumulating evidence in multiple rheumatic diseases indicates that gender may influence the likelihood of achieving the desired outcome with treatment,” but studies of differences in treatment response according to gender are limited, they said.
The researchers conducted a post hoc analysis of women and men with PsA who were part of PsABio, a noninterventional European study of patients with PsA. All participants were starting first-, second-, or third-line treatment with ustekinumab or a TNF inhibitor. The primary outcome was response to treatment at 12 months. Disease activity was assessed using the clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), the Health Assessment Questionnaire–Disability Index (HAQ-DI), and total score on the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire.
Baseline available data for 512 women and 417 men showed the mean duration of disease was similar between genders (6.7 years for females and 6.9 years for males); body mass index was similar, as was the proportion of male and female patients receiving concomitant conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Females scored significantly worse than males on disease activity assessments at baseline with mean cDAPSA scores of 32.3 and 26.8, respectively.
The final analysis of 895 patients with baseline data and a postbaseline assessment included 439 who started ustekinumab (247 females, 192 males), and 456 who started a TNF inhibitor (248 females, 208 males).
At 12 months, females showed smaller degrees of improvement than males; 57.8% and 80.3%, respectively, achieved low disease activity based on cDAPSA scores, while 33.7% and 55.5% of females and males, respectively, achieved minimal disease activity. Measures of disability were higher in females than males, with HAQ-DI scores of 0.85 versus 0.50. PsAID-12 scores also were higher for females, compared with males (3.5 vs. 2.4).
A total of 81.7% of patients were on their initial biologic DMARD after 12 months, but more females than males who were taking ustekinumab or a TNF inhibitor changed or discontinued treatment.
Treatment persistence was significantly lower in females than males (P = .01), and lack of effectiveness was the main reason for discontinuation regardless of gender.
“The analysis of gender subgroup results of the PsABio study has expanded previously published observations that men and women with PsA have different experiences with the disease activity, clinical manifestations, impact on health-related quality of life, response to [biologic] DMARDs, and drug persistence,” the researchers wrote.
The lack of a medication protocol in the PsABio study limited the conclusions that could be drawn from the post hoc analysis, but the results were strengthened by the relatively large and diverse sample size and the inclusion of responses to more than one medication, the researchers noted.
The study was supported by Janssen. Dr. Van Kuijk disclosed serving as a consultant and receiving grant support from Janssen and other companies; several coauthors also disclosed relationships with Janssen.
Women with psoriatic arthritis (PsA) presented with more severe disease at baseline and were less likely to achieve favorable outcomes after 12 months of treatment with either ustekinumab (Stelara) or a tumor necrosis factor (TNF) inhibitor, compared with men, according to a post hoc analysis of data from nearly 1,000 individuals.
Although data suggest that the overall prevalence of PsA is similar across genders, recent studies have identified differences in various aspects of PsA between men and women, wrote Arno W.R. Van Kuijk, MD, of Amsterdam Rheumatology and Immunology Center, and colleagues wrote in a study published in Rheumatology.
“Accumulating evidence in multiple rheumatic diseases indicates that gender may influence the likelihood of achieving the desired outcome with treatment,” but studies of differences in treatment response according to gender are limited, they said.
The researchers conducted a post hoc analysis of women and men with PsA who were part of PsABio, a noninterventional European study of patients with PsA. All participants were starting first-, second-, or third-line treatment with ustekinumab or a TNF inhibitor. The primary outcome was response to treatment at 12 months. Disease activity was assessed using the clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), the Health Assessment Questionnaire–Disability Index (HAQ-DI), and total score on the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire.
Baseline available data for 512 women and 417 men showed the mean duration of disease was similar between genders (6.7 years for females and 6.9 years for males); body mass index was similar, as was the proportion of male and female patients receiving concomitant conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Females scored significantly worse than males on disease activity assessments at baseline with mean cDAPSA scores of 32.3 and 26.8, respectively.
The final analysis of 895 patients with baseline data and a postbaseline assessment included 439 who started ustekinumab (247 females, 192 males), and 456 who started a TNF inhibitor (248 females, 208 males).
At 12 months, females showed smaller degrees of improvement than males; 57.8% and 80.3%, respectively, achieved low disease activity based on cDAPSA scores, while 33.7% and 55.5% of females and males, respectively, achieved minimal disease activity. Measures of disability were higher in females than males, with HAQ-DI scores of 0.85 versus 0.50. PsAID-12 scores also were higher for females, compared with males (3.5 vs. 2.4).
A total of 81.7% of patients were on their initial biologic DMARD after 12 months, but more females than males who were taking ustekinumab or a TNF inhibitor changed or discontinued treatment.
Treatment persistence was significantly lower in females than males (P = .01), and lack of effectiveness was the main reason for discontinuation regardless of gender.
“The analysis of gender subgroup results of the PsABio study has expanded previously published observations that men and women with PsA have different experiences with the disease activity, clinical manifestations, impact on health-related quality of life, response to [biologic] DMARDs, and drug persistence,” the researchers wrote.
The lack of a medication protocol in the PsABio study limited the conclusions that could be drawn from the post hoc analysis, but the results were strengthened by the relatively large and diverse sample size and the inclusion of responses to more than one medication, the researchers noted.
The study was supported by Janssen. Dr. Van Kuijk disclosed serving as a consultant and receiving grant support from Janssen and other companies; several coauthors also disclosed relationships with Janssen.
FROM RHEUMATOLOGY
Commentary: Concerning PsA treatments and comorbidities, March 2023
Psoriatic arthritis (PsA) is a heterogeneous disease with clinical manifestations affecting the skin, joints, spine, and periarticular structures, such as the entheses and tendons. The impact of these manifestations individually on health-related quality of life (QOL) and physical function is less studied. Using data from a cross-sectional observational study including 2222 patients with a physician-confirmed diagnosis of PsA, Walsh and colleagues report that the presence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was significantly associated with worse QOL and self-rated health when compared with patients without these manifestations. Moreover, an increasing number of affected joints and greater body surface area with psoriasis were significantly correlated with poorer functional state and greater work productivity impairment. This study provides further insights into the effect of the different domains of PsA on the patient. Clinicians managing PsA should therefore evaluate these domains and aim to reduce disease activity in each domain to improve QOL and function.
With regard to advanced targeted therapies, there is concern about the side effects of Janus kinase (JAK) inhibitors, especially in patients with comorbidities. To address safety concerns with upadacitinib, a selective JAK1 inhibitor, Burmester and colleagues conducted an integrated safety analysis of 12 phase 3 trials that included 6991 patients (PsA n = 907; rheumatoid arthritis [RA] n = 3209; ankylosing spondylitis n = 182; and atopic dermatitis n = 2693) who received upadacitinib (15 or 30 mg once daily). Some trials included active comparators; therefore, safety among 1008 patients (RA n = 579; PsA n = 429) who received 40-mg adalimumab every other week and 314 patients with RA who received methotrexate were compared with those treated with upadacitinib. Overall, patients with PsA receiving 15-mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and death (0.8/100 PY). Patients with PsA treated with upadacitinib had higher rates of herpes zoster, nonmelanoma skin cancer, and elevations in creatine phosphokinase when compared with patients treated with adalimumab. Although these results are reassuring to clinicians treating PsA, continued surveillance regarding the risks for venous thrombosis, cardiovascular events, and cancer are required.
In a post hoc analysis of 10 clinical trials that included patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib, Kristensen and colleagues reported that the risk for major adverse cardiac events was higher among patients with PsA and a high 10-year atherosclerotic cardiovascular disease (ASCVD) risk vs patients with a low ASCVD risk. The incidence of cancer was highest in patients with PsA and an intermediate 10-year ASCVD risk. Although these studies are reassuring, the assessment and risk stratification of adverse events with JAK inhibitors and therapies in PsA will require longer-term comparative clinical trials as well as an evaluation of observational data from disease registries.
Comorbidities also have an impact on treatment persistence in PsA. Tillett and colleagues conducted a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs. They demonstrated that among patients receiving ustekinumab, those with concomitant PsA had a higher comorbidity burden, including diabetes, hypertension, and obesity, and a shorter time to ustekinumab discontinuation when compared with those with psoriasis alone. Secondary failure of advanced therapies is increasingly noted in the management of psoriatic disease. Female sex, depression, previous exposure to biologics, and the presence of comorbidities are important risk factors. Comprehensive management of psoriatic disease should include appropriate management of comorbidities for better long-term treatment persistence and outcomes.
Psoriatic arthritis (PsA) is a heterogeneous disease with clinical manifestations affecting the skin, joints, spine, and periarticular structures, such as the entheses and tendons. The impact of these manifestations individually on health-related quality of life (QOL) and physical function is less studied. Using data from a cross-sectional observational study including 2222 patients with a physician-confirmed diagnosis of PsA, Walsh and colleagues report that the presence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was significantly associated with worse QOL and self-rated health when compared with patients without these manifestations. Moreover, an increasing number of affected joints and greater body surface area with psoriasis were significantly correlated with poorer functional state and greater work productivity impairment. This study provides further insights into the effect of the different domains of PsA on the patient. Clinicians managing PsA should therefore evaluate these domains and aim to reduce disease activity in each domain to improve QOL and function.
With regard to advanced targeted therapies, there is concern about the side effects of Janus kinase (JAK) inhibitors, especially in patients with comorbidities. To address safety concerns with upadacitinib, a selective JAK1 inhibitor, Burmester and colleagues conducted an integrated safety analysis of 12 phase 3 trials that included 6991 patients (PsA n = 907; rheumatoid arthritis [RA] n = 3209; ankylosing spondylitis n = 182; and atopic dermatitis n = 2693) who received upadacitinib (15 or 30 mg once daily). Some trials included active comparators; therefore, safety among 1008 patients (RA n = 579; PsA n = 429) who received 40-mg adalimumab every other week and 314 patients with RA who received methotrexate were compared with those treated with upadacitinib. Overall, patients with PsA receiving 15-mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and death (0.8/100 PY). Patients with PsA treated with upadacitinib had higher rates of herpes zoster, nonmelanoma skin cancer, and elevations in creatine phosphokinase when compared with patients treated with adalimumab. Although these results are reassuring to clinicians treating PsA, continued surveillance regarding the risks for venous thrombosis, cardiovascular events, and cancer are required.
In a post hoc analysis of 10 clinical trials that included patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib, Kristensen and colleagues reported that the risk for major adverse cardiac events was higher among patients with PsA and a high 10-year atherosclerotic cardiovascular disease (ASCVD) risk vs patients with a low ASCVD risk. The incidence of cancer was highest in patients with PsA and an intermediate 10-year ASCVD risk. Although these studies are reassuring, the assessment and risk stratification of adverse events with JAK inhibitors and therapies in PsA will require longer-term comparative clinical trials as well as an evaluation of observational data from disease registries.
Comorbidities also have an impact on treatment persistence in PsA. Tillett and colleagues conducted a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs. They demonstrated that among patients receiving ustekinumab, those with concomitant PsA had a higher comorbidity burden, including diabetes, hypertension, and obesity, and a shorter time to ustekinumab discontinuation when compared with those with psoriasis alone. Secondary failure of advanced therapies is increasingly noted in the management of psoriatic disease. Female sex, depression, previous exposure to biologics, and the presence of comorbidities are important risk factors. Comprehensive management of psoriatic disease should include appropriate management of comorbidities for better long-term treatment persistence and outcomes.
Psoriatic arthritis (PsA) is a heterogeneous disease with clinical manifestations affecting the skin, joints, spine, and periarticular structures, such as the entheses and tendons. The impact of these manifestations individually on health-related quality of life (QOL) and physical function is less studied. Using data from a cross-sectional observational study including 2222 patients with a physician-confirmed diagnosis of PsA, Walsh and colleagues report that the presence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was significantly associated with worse QOL and self-rated health when compared with patients without these manifestations. Moreover, an increasing number of affected joints and greater body surface area with psoriasis were significantly correlated with poorer functional state and greater work productivity impairment. This study provides further insights into the effect of the different domains of PsA on the patient. Clinicians managing PsA should therefore evaluate these domains and aim to reduce disease activity in each domain to improve QOL and function.
With regard to advanced targeted therapies, there is concern about the side effects of Janus kinase (JAK) inhibitors, especially in patients with comorbidities. To address safety concerns with upadacitinib, a selective JAK1 inhibitor, Burmester and colleagues conducted an integrated safety analysis of 12 phase 3 trials that included 6991 patients (PsA n = 907; rheumatoid arthritis [RA] n = 3209; ankylosing spondylitis n = 182; and atopic dermatitis n = 2693) who received upadacitinib (15 or 30 mg once daily). Some trials included active comparators; therefore, safety among 1008 patients (RA n = 579; PsA n = 429) who received 40-mg adalimumab every other week and 314 patients with RA who received methotrexate were compared with those treated with upadacitinib. Overall, patients with PsA receiving 15-mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and death (0.8/100 PY). Patients with PsA treated with upadacitinib had higher rates of herpes zoster, nonmelanoma skin cancer, and elevations in creatine phosphokinase when compared with patients treated with adalimumab. Although these results are reassuring to clinicians treating PsA, continued surveillance regarding the risks for venous thrombosis, cardiovascular events, and cancer are required.
In a post hoc analysis of 10 clinical trials that included patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib, Kristensen and colleagues reported that the risk for major adverse cardiac events was higher among patients with PsA and a high 10-year atherosclerotic cardiovascular disease (ASCVD) risk vs patients with a low ASCVD risk. The incidence of cancer was highest in patients with PsA and an intermediate 10-year ASCVD risk. Although these studies are reassuring, the assessment and risk stratification of adverse events with JAK inhibitors and therapies in PsA will require longer-term comparative clinical trials as well as an evaluation of observational data from disease registries.
Comorbidities also have an impact on treatment persistence in PsA. Tillett and colleagues conducted a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs. They demonstrated that among patients receiving ustekinumab, those with concomitant PsA had a higher comorbidity burden, including diabetes, hypertension, and obesity, and a shorter time to ustekinumab discontinuation when compared with those with psoriasis alone. Secondary failure of advanced therapies is increasingly noted in the management of psoriatic disease. Female sex, depression, previous exposure to biologics, and the presence of comorbidities are important risk factors. Comprehensive management of psoriatic disease should include appropriate management of comorbidities for better long-term treatment persistence and outcomes.
PsA: Baseline disease activity predicts DAPSA response in patients treated with apremilast
Key clinical point: Nearly half of the patients with psoriatic arthritis (PsA) treated with apremilast achieved disease activity index for psoriatic arthritis (DAPSA) low disease activity/remission at 6 or 12 months, with lower baseline disease activity being the only factor associated with the achievement of low disease activity or remission.
Major finding: Overall, 42.7% and 54.9% of patients achieved DAPSA low disease activity or remission at 6 and 12 months, respectively. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio [OR] 0.84) and 12 months (OR 0.91; both P < .01).
Study details: Findings are from a retrospective study including 293 patients with PsA who were treated with apremilast.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Becciolini A et al. Predictors of DAPSA response in psoriatic arthritis patients treated with apremilast in a retrospective observational multi-centric study. Biomedicines. 2023;11(2):433 (Feb 2). Doi: 10.3390/biomedicines11020433
Key clinical point: Nearly half of the patients with psoriatic arthritis (PsA) treated with apremilast achieved disease activity index for psoriatic arthritis (DAPSA) low disease activity/remission at 6 or 12 months, with lower baseline disease activity being the only factor associated with the achievement of low disease activity or remission.
Major finding: Overall, 42.7% and 54.9% of patients achieved DAPSA low disease activity or remission at 6 and 12 months, respectively. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio [OR] 0.84) and 12 months (OR 0.91; both P < .01).
Study details: Findings are from a retrospective study including 293 patients with PsA who were treated with apremilast.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Becciolini A et al. Predictors of DAPSA response in psoriatic arthritis patients treated with apremilast in a retrospective observational multi-centric study. Biomedicines. 2023;11(2):433 (Feb 2). Doi: 10.3390/biomedicines11020433
Key clinical point: Nearly half of the patients with psoriatic arthritis (PsA) treated with apremilast achieved disease activity index for psoriatic arthritis (DAPSA) low disease activity/remission at 6 or 12 months, with lower baseline disease activity being the only factor associated with the achievement of low disease activity or remission.
Major finding: Overall, 42.7% and 54.9% of patients achieved DAPSA low disease activity or remission at 6 and 12 months, respectively. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio [OR] 0.84) and 12 months (OR 0.91; both P < .01).
Study details: Findings are from a retrospective study including 293 patients with PsA who were treated with apremilast.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Becciolini A et al. Predictors of DAPSA response in psoriatic arthritis patients treated with apremilast in a retrospective observational multi-centric study. Biomedicines. 2023;11(2):433 (Feb 2). Doi: 10.3390/biomedicines11020433
Long-term safety and tolerability of upadacitinib in PsA
Key clinical point: Upadacitinib demonstrated an acceptable long-term safety profile and was generally well tolerated with no new safety signals in patients with psoriatic arthritis (PsA).
Major finding: Overall, patients with PsA receiving 15 mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and deaths (0.8/100 PY).
Study details: This integrated safety analysis of 12 phase 3 trials included 6991 patients with PsA (n = 907), rheumatoid arthritis (n = 3,209), ankylosing spondylitis (n = 182), and atopic dermatitis (n = 2693) who received upadacitinib (15 or 30 mg once daily); 1008 patients with RA (n = 579) and PsA (n = 429) who received 40 mg adalimumab every other week; and 314 patients with RA who received methotrexate.
Disclosures: This study was funded by AbbVie. Five authors declared being full-time employees of AbbVie or Mount Sinai or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.
Source: Burmester GR et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735;15(Feb 8). Doi: 10.1136/rmdopen-2022-002735
Key clinical point: Upadacitinib demonstrated an acceptable long-term safety profile and was generally well tolerated with no new safety signals in patients with psoriatic arthritis (PsA).
Major finding: Overall, patients with PsA receiving 15 mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and deaths (0.8/100 PY).
Study details: This integrated safety analysis of 12 phase 3 trials included 6991 patients with PsA (n = 907), rheumatoid arthritis (n = 3,209), ankylosing spondylitis (n = 182), and atopic dermatitis (n = 2693) who received upadacitinib (15 or 30 mg once daily); 1008 patients with RA (n = 579) and PsA (n = 429) who received 40 mg adalimumab every other week; and 314 patients with RA who received methotrexate.
Disclosures: This study was funded by AbbVie. Five authors declared being full-time employees of AbbVie or Mount Sinai or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.
Source: Burmester GR et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735;15(Feb 8). Doi: 10.1136/rmdopen-2022-002735
Key clinical point: Upadacitinib demonstrated an acceptable long-term safety profile and was generally well tolerated with no new safety signals in patients with psoriatic arthritis (PsA).
Major finding: Overall, patients with PsA receiving 15 mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and deaths (0.8/100 PY).
Study details: This integrated safety analysis of 12 phase 3 trials included 6991 patients with PsA (n = 907), rheumatoid arthritis (n = 3,209), ankylosing spondylitis (n = 182), and atopic dermatitis (n = 2693) who received upadacitinib (15 or 30 mg once daily); 1008 patients with RA (n = 579) and PsA (n = 429) who received 40 mg adalimumab every other week; and 314 patients with RA who received methotrexate.
Disclosures: This study was funded by AbbVie. Five authors declared being full-time employees of AbbVie or Mount Sinai or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.
Source: Burmester GR et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735;15(Feb 8). Doi: 10.1136/rmdopen-2022-002735
Baseline cardiovascular risk may influence MACE and malignancy incidences in tofacitinib-treated PsA patients
Key clinical point: Preventive monitoring for cardiovascular risk is suggested in tofacitinib-treated patients with psoriatic arthritis (PsA) as higher atherosclerotic cardiovascular disease (ASCVD) risk appears to be associated with a higher incidence of major cardiovascular events (MACE) and malignancies.
Major finding: The risk for MACE appeared to be higher among patients with PsA and high vs low 10-year ASCVD risk (incidence rate [IR] 1.37 [95% CI 0.03-7.63] vs 0.08 [95% CI 0.0-0.42]), with the incidence of malignancies being the highest in patients with PsA and an intermediate 10-year ASCVD risk (IR 2.56, 95% CI 1.11-5.05).
Study details: Findings are from a post hoc analysis of 10 clinical trials including patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib.
Disclosures: This study was sponsored by Pfizer. Some authors declared receiving speaker fees or grant or research support or serving as consultants for various sources, including Pfizer. Some authors declared being employees and shareholders of Pfizer or Syneos Health, a paid contractor to Pfizer.
Source: Kristensen LE et al. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 (Feb 7). Doi: 10.1177/1759720X221149965
Key clinical point: Preventive monitoring for cardiovascular risk is suggested in tofacitinib-treated patients with psoriatic arthritis (PsA) as higher atherosclerotic cardiovascular disease (ASCVD) risk appears to be associated with a higher incidence of major cardiovascular events (MACE) and malignancies.
Major finding: The risk for MACE appeared to be higher among patients with PsA and high vs low 10-year ASCVD risk (incidence rate [IR] 1.37 [95% CI 0.03-7.63] vs 0.08 [95% CI 0.0-0.42]), with the incidence of malignancies being the highest in patients with PsA and an intermediate 10-year ASCVD risk (IR 2.56, 95% CI 1.11-5.05).
Study details: Findings are from a post hoc analysis of 10 clinical trials including patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib.
Disclosures: This study was sponsored by Pfizer. Some authors declared receiving speaker fees or grant or research support or serving as consultants for various sources, including Pfizer. Some authors declared being employees and shareholders of Pfizer or Syneos Health, a paid contractor to Pfizer.
Source: Kristensen LE et al. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 (Feb 7). Doi: 10.1177/1759720X221149965
Key clinical point: Preventive monitoring for cardiovascular risk is suggested in tofacitinib-treated patients with psoriatic arthritis (PsA) as higher atherosclerotic cardiovascular disease (ASCVD) risk appears to be associated with a higher incidence of major cardiovascular events (MACE) and malignancies.
Major finding: The risk for MACE appeared to be higher among patients with PsA and high vs low 10-year ASCVD risk (incidence rate [IR] 1.37 [95% CI 0.03-7.63] vs 0.08 [95% CI 0.0-0.42]), with the incidence of malignancies being the highest in patients with PsA and an intermediate 10-year ASCVD risk (IR 2.56, 95% CI 1.11-5.05).
Study details: Findings are from a post hoc analysis of 10 clinical trials including patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib.
Disclosures: This study was sponsored by Pfizer. Some authors declared receiving speaker fees or grant or research support or serving as consultants for various sources, including Pfizer. Some authors declared being employees and shareholders of Pfizer or Syneos Health, a paid contractor to Pfizer.
Source: Kristensen LE et al. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 (Feb 7). Doi: 10.1177/1759720X221149965
Circulating microRNA can differentiate between psoriasis and psoriatic arthritis
Key clinical point: Signatures of circulating microRNA in patients with psoriatic arthritis (PsA) and patients with psoriasis were significantly different from those in control individuals, with some even being differentially regulated between PsA and psoriasis.
Major finding: Overall, 9 microRNA best differentiated patients with PsA and psoriasis from control individuals (area under the curve [AUC] ≥0.70; all P < .05) and 4 microRNA best differentiated patients with PsA from patients with psoriasis (all P < .05). A combination of 4 microRNA (miR-19b-3p, miR-21-5p, miR-92a-3p, and let-7b-5p) vs miR-92a-3p alone could better differentiate between patients with PsA and psoriasis (AUC 0.92 vs 0.82).
Study details: This cross-sectional study included 51 patients with PsA, 40 patients with psoriasis, and 50 control individuals.
Disclosures: This study did not receive any specific funding. Two authors declared being employees or shareholders of TAmiRNA GmbH or holding intellectual property for the diagnostic use of microRNA in bone diseases.
Source: Haschka J et al. Identification of circulating microRNA patterns in patients in psoriasis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Feb 3). Doi: 10.1093/rheumatology/kead059
Key clinical point: Signatures of circulating microRNA in patients with psoriatic arthritis (PsA) and patients with psoriasis were significantly different from those in control individuals, with some even being differentially regulated between PsA and psoriasis.
Major finding: Overall, 9 microRNA best differentiated patients with PsA and psoriasis from control individuals (area under the curve [AUC] ≥0.70; all P < .05) and 4 microRNA best differentiated patients with PsA from patients with psoriasis (all P < .05). A combination of 4 microRNA (miR-19b-3p, miR-21-5p, miR-92a-3p, and let-7b-5p) vs miR-92a-3p alone could better differentiate between patients with PsA and psoriasis (AUC 0.92 vs 0.82).
Study details: This cross-sectional study included 51 patients with PsA, 40 patients with psoriasis, and 50 control individuals.
Disclosures: This study did not receive any specific funding. Two authors declared being employees or shareholders of TAmiRNA GmbH or holding intellectual property for the diagnostic use of microRNA in bone diseases.
Source: Haschka J et al. Identification of circulating microRNA patterns in patients in psoriasis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Feb 3). Doi: 10.1093/rheumatology/kead059
Key clinical point: Signatures of circulating microRNA in patients with psoriatic arthritis (PsA) and patients with psoriasis were significantly different from those in control individuals, with some even being differentially regulated between PsA and psoriasis.
Major finding: Overall, 9 microRNA best differentiated patients with PsA and psoriasis from control individuals (area under the curve [AUC] ≥0.70; all P < .05) and 4 microRNA best differentiated patients with PsA from patients with psoriasis (all P < .05). A combination of 4 microRNA (miR-19b-3p, miR-21-5p, miR-92a-3p, and let-7b-5p) vs miR-92a-3p alone could better differentiate between patients with PsA and psoriasis (AUC 0.92 vs 0.82).
Study details: This cross-sectional study included 51 patients with PsA, 40 patients with psoriasis, and 50 control individuals.
Disclosures: This study did not receive any specific funding. Two authors declared being employees or shareholders of TAmiRNA GmbH or holding intellectual property for the diagnostic use of microRNA in bone diseases.
Source: Haschka J et al. Identification of circulating microRNA patterns in patients in psoriasis and psoriatic arthritis. Rheumatology (Oxford). 2023 (Feb 3). Doi: 10.1093/rheumatology/kead059
Crude mortality rate doubled in PsA patients during COVID-19 pandemic
Key clinical point: The crude mortality rate increased by two-fold in patients with psoriatic arthritis (PsA) during the COVID-19 pandemic compared with the pre-pandemic era, with pulmonary reasons being the major risk factors for mortality.
Major finding: Although standard mortality rates were similar between patients with PsA and the general population during the pre-pandemic period (0.95; 95% CI 0.61-1.49), the crude mortality rate, which was 5.07 before the pandemic, increased by 2.12-fold during the pandemic in the PsA population. Interestingly, deaths due to pulmonary reasons increased from 6% during the pre-pandemic era to 66% during the pandemic.
Study details: Findings are from an international multicenter registry study including 1216 patients with PsA who were followed up for 7500 patient-years.
Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria or research grants from several sources.
Source: Erden A et al. Mortality in psoriatic arthritis patients, changes over time, and the impact of COVID-19: Results from a multicenter Psoriatic Arthritis Registry (PsART-ID). Clin Rheumatol. 2023;42(2):385-390(Jan 13). Doi: 10.1007/s10067-022-06492-6
Key clinical point: The crude mortality rate increased by two-fold in patients with psoriatic arthritis (PsA) during the COVID-19 pandemic compared with the pre-pandemic era, with pulmonary reasons being the major risk factors for mortality.
Major finding: Although standard mortality rates were similar between patients with PsA and the general population during the pre-pandemic period (0.95; 95% CI 0.61-1.49), the crude mortality rate, which was 5.07 before the pandemic, increased by 2.12-fold during the pandemic in the PsA population. Interestingly, deaths due to pulmonary reasons increased from 6% during the pre-pandemic era to 66% during the pandemic.
Study details: Findings are from an international multicenter registry study including 1216 patients with PsA who were followed up for 7500 patient-years.
Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria or research grants from several sources.
Source: Erden A et al. Mortality in psoriatic arthritis patients, changes over time, and the impact of COVID-19: Results from a multicenter Psoriatic Arthritis Registry (PsART-ID). Clin Rheumatol. 2023;42(2):385-390(Jan 13). Doi: 10.1007/s10067-022-06492-6
Key clinical point: The crude mortality rate increased by two-fold in patients with psoriatic arthritis (PsA) during the COVID-19 pandemic compared with the pre-pandemic era, with pulmonary reasons being the major risk factors for mortality.
Major finding: Although standard mortality rates were similar between patients with PsA and the general population during the pre-pandemic period (0.95; 95% CI 0.61-1.49), the crude mortality rate, which was 5.07 before the pandemic, increased by 2.12-fold during the pandemic in the PsA population. Interestingly, deaths due to pulmonary reasons increased from 6% during the pre-pandemic era to 66% during the pandemic.
Study details: Findings are from an international multicenter registry study including 1216 patients with PsA who were followed up for 7500 patient-years.
Disclosures: This study did not report the source of funding. Some authors declared receiving honoraria or research grants from several sources.
Source: Erden A et al. Mortality in psoriatic arthritis patients, changes over time, and the impact of COVID-19: Results from a multicenter Psoriatic Arthritis Registry (PsART-ID). Clin Rheumatol. 2023;42(2):385-390(Jan 13). Doi: 10.1007/s10067-022-06492-6
Real-world evidence on impact of PsA manifestation on patient outcomes
Key clinical point: All multiple manifestations of psoriatic arthritis (PsA) negatively affect quality of life (QoL), with dactylitis, peripheral joint disease, and psoriasis impairing functional status, whereas joint, skin, and periarticular symptoms independently impair work productivity.
Major finding: Presence vs absence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was associated with worse QoL and self-rated health (all P < .05), whereas increasing number of affected joints and greater body surface area involvement significantly correlated with poorer functional state and greater work productivity impairment (all P < .05).
Study details: Findings are from a cross-sectional observational study including 2222 patients with physician-confirmed diagnosis of PsA.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants from, serving as a consultant for, being an employee of, or owning shares in different sources.
Source: Walsh JA et al. Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023;105534 (Jan 25). Doi: 10.1016/j.jbspin.2023.105534
Key clinical point: All multiple manifestations of psoriatic arthritis (PsA) negatively affect quality of life (QoL), with dactylitis, peripheral joint disease, and psoriasis impairing functional status, whereas joint, skin, and periarticular symptoms independently impair work productivity.
Major finding: Presence vs absence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was associated with worse QoL and self-rated health (all P < .05), whereas increasing number of affected joints and greater body surface area involvement significantly correlated with poorer functional state and greater work productivity impairment (all P < .05).
Study details: Findings are from a cross-sectional observational study including 2222 patients with physician-confirmed diagnosis of PsA.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants from, serving as a consultant for, being an employee of, or owning shares in different sources.
Source: Walsh JA et al. Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023;105534 (Jan 25). Doi: 10.1016/j.jbspin.2023.105534
Key clinical point: All multiple manifestations of psoriatic arthritis (PsA) negatively affect quality of life (QoL), with dactylitis, peripheral joint disease, and psoriasis impairing functional status, whereas joint, skin, and periarticular symptoms independently impair work productivity.
Major finding: Presence vs absence of enthesitis, dactylitis, inflammatory back pain, and peripheral joint involvement was associated with worse QoL and self-rated health (all P < .05), whereas increasing number of affected joints and greater body surface area involvement significantly correlated with poorer functional state and greater work productivity impairment (all P < .05).
Study details: Findings are from a cross-sectional observational study including 2222 patients with physician-confirmed diagnosis of PsA.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants from, serving as a consultant for, being an employee of, or owning shares in different sources.
Source: Walsh JA et al. Impact of key manifestations of psoriatic arthritis on patient quality of life, functional status, and work productivity: Findings from a real-world study in the United States and Europe. Joint Bone Spine. 2023;105534 (Jan 25). Doi: 10.1016/j.jbspin.2023.105534