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FDA approves Idacio as eighth adalimumab biosimilar in U.S.

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A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

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A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

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

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Ustekinumab matches TNF inhibitors for psoriatic arthritis in 3-year, real-world study

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The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

Dr. Laure Gossec

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.



Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

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The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

Dr. Laure Gossec

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.



Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

The interleukin-12/23 inhibitor ustekinumab (Stelara) is nearly as effective as a tumor necrosis factor (TNF) inhibitor for psoriatic arthritis, and patients are slightly more likely to persist with it and have a lower rate of adverse events, a 3-year, real-world study has found.

In a paper published online in Annals of the Rheumatic Diseases, researchers presented the outcomes of the prospective, observational PsABio study of 895 adults with psoriatic arthritis, who were starting treatment for the first time with either ustekinumab or a TNF inhibitor as first-, second-, or third-line treatment.

At 3 years after starting therapy, 49.9% of the 439 patients prescribed ustekinumab were still on that treatment, compared with 47.8% of the 456 patients prescribed a TNF inhibitor. However, there were differences in persistence based on clinical presentation. Patients who had severe skin involvement who were treated with ustekinumab stayed on the drug for longer than did those with severe skin involvement treated with a TNF inhibitor, and they were more likely to persist with their treatment for the 3 years of the study. However, there were numerically more patients with mild or moderate skin involvement taking a TNF inhibitor who stayed persistent with the treatment, compared with those taking ustekinumab, although the differences were not statistically significant.

“In the ustekinumab group, skin response was an important reason for prolonged persistence, with more patients in the ustekinumab group stopping/switching due to lack of effectiveness,” wrote Laure Gossec, MD, of Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and coauthors. “This is expected, as psoriasis can significantly affect morbidity, and successfully treating skin symptoms improves patients’ health-related quality of life.”

Dr. Laure Gossec

The authors also noted that patients on ustekinumab monotherapy had the highest rate of persistence and stayed on treatment longer than did those on TNF inhibitor monotherapy, or on dual therapy with either drug combined with methotrexate. They suggested this could be because patients on TNF inhibitor monotherapy may be more likely to develop antidrug antibodies than those on ustekinumab monotherapy. It could also be because adding methotrexate may increase the risk of adverse events, but without necessarily increasing the effectiveness of ustekinumab on skin involvement.

In terms of efficacy, researchers saw that 69.8% of patients in the TNF inhibitor group had achieved low disease activity and 45% had achieved remission, compared with 58.6% of patients in the ustekinumab group who achieved low disease activity and 31.4% who achieved remission.

A similar pattern was seen for minimal disease activity and very low disease activity, which were achieved by 54.2% and 26.9% respectively of those in the TNF inhibitor group, and 41.4% and 19.2% respectively of those in the ustekinumab group.



Because the study was observational and real-world, the choice of therapy was made by the treating rheumatologist rather than patients being randomized. There were some baseline differences between the ustekinumab and TNF inhibitor groups; for example, patients in ustekinumab group were generally older and with more comorbidities, and were more likely to have previous been treated with biologics. However, they were also less likely to be concurrently treated with methotrexate and NSAIDs, and more likely to have severe skin involvement.

The study saw a higher rate of adverse events in the TNF inhibitor group, compared with the ustekinumab, with 39.7% of patients treated with TNF inhibitor and 34.6% of those treated with ustekinumab reporting at least one adverse event. The rates of serious adverse events and malignancies were similar for the two groups, but overall the ustekinumab group had a lower rate of clinically-relevant adverse events including infections.

The study was sponsored by Janssen, which markets ustekinumab. Ten authors declared personal fees, grants, and nonfinancial support from the pharmaceutical sector, including Janssen. One author was an employee of Janssen, one an employee of Johnson & Johnson, and two are editorial board members of Annals of the Rheumatic Diseases.

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Meta-analysis fails to identify specific diagnostic biomarker for PsA

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Key clinical point: Although a few biomarkers can assist in distinguishing psoriatic arthritis (PsA) from psoriasis or osteoarthritis, a precise diagnostic biomarker that can distinguish PsA from osteoarthritis and most other chronic inflammatory diseases has not yet been identified.

Major finding: Serum cartilage oligometrix metalloproteinase levels were significantly increased in patients with PsA compared with control individuals without chronic inflammatory diseases (standardized mean difference [SMD] 2.305; P = .003) and patients with osteoarthritis (SMD 0.783; P = .046). Serum matrix metalloproteinase-3 levels were significantly higher in patients with PsA vs psoriasis (SMD 0.419; P = .006) but could not distinguish patients with PsA from control individuals.

Study details: Findings are from a meta-analysis of 124 studies including patients with PsA.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Wirth T et al. Biomarkers in psoriatic arthritis: A meta-analysis and systematic review. Front Immunol. 2022;13:1054539 (Nov 30). Doi: 10.3389/fimmu.2022.1054539

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Key clinical point: Although a few biomarkers can assist in distinguishing psoriatic arthritis (PsA) from psoriasis or osteoarthritis, a precise diagnostic biomarker that can distinguish PsA from osteoarthritis and most other chronic inflammatory diseases has not yet been identified.

Major finding: Serum cartilage oligometrix metalloproteinase levels were significantly increased in patients with PsA compared with control individuals without chronic inflammatory diseases (standardized mean difference [SMD] 2.305; P = .003) and patients with osteoarthritis (SMD 0.783; P = .046). Serum matrix metalloproteinase-3 levels were significantly higher in patients with PsA vs psoriasis (SMD 0.419; P = .006) but could not distinguish patients with PsA from control individuals.

Study details: Findings are from a meta-analysis of 124 studies including patients with PsA.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Wirth T et al. Biomarkers in psoriatic arthritis: A meta-analysis and systematic review. Front Immunol. 2022;13:1054539 (Nov 30). Doi: 10.3389/fimmu.2022.1054539

Key clinical point: Although a few biomarkers can assist in distinguishing psoriatic arthritis (PsA) from psoriasis or osteoarthritis, a precise diagnostic biomarker that can distinguish PsA from osteoarthritis and most other chronic inflammatory diseases has not yet been identified.

Major finding: Serum cartilage oligometrix metalloproteinase levels were significantly increased in patients with PsA compared with control individuals without chronic inflammatory diseases (standardized mean difference [SMD] 2.305; P = .003) and patients with osteoarthritis (SMD 0.783; P = .046). Serum matrix metalloproteinase-3 levels were significantly higher in patients with PsA vs psoriasis (SMD 0.419; P = .006) but could not distinguish patients with PsA from control individuals.

Study details: Findings are from a meta-analysis of 124 studies including patients with PsA.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Wirth T et al. Biomarkers in psoriatic arthritis: A meta-analysis and systematic review. Front Immunol. 2022;13:1054539 (Nov 30). Doi: 10.3389/fimmu.2022.1054539

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Axial PsA: A distinct phenotype not to be confused with ankylosing spondylitis+psoriasis

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Key clinical point: Axial psoriatic arthritis (PsA) can be categorized as a distinct subtype of PsA because it exhibits clinical and radiological symptoms that are different from those of ankylosing spondylitis (AS) with psoriasis.

Major finding: Compared with patients with AS and psoriasis, patients with human leukocyte antigen (HLA)-B27-negative axial PsA had lesser inflammatory pain (P = .002), anterior uveitis (P = .014), and structural damage (P < .001) along with a higher prevalence of nail disease (P = .009) and were more likely to present with psoriasis before spondyloarthritis onset (P = .020). However, patients with HLA-B27-positive axial PsA vs AS and psoriasis reported lesser structural damage as revealed by Bath Ankylosing Spondylitis Radiology Index scores (P < .001).

Study details: This cross-sectional study included 109 patients with axial PsA and 127 patients with AS and current presentation or a history of skin psoriasis from the REGISPONSER registry.

Disclosures: The REGISPONSER registry is funded by the Spanish Society for Rheumatology. The authors declared no conflicts of interest.

Source: Michelena X et al. Characterising the axial phenotype of psoriatic arthritis: a study comparing axial psoriatic arthritis and ankylosing spondylitis with psoriasis from the REGISPONSER registry. RMD Open. 2022;8:e002513 (Dec 5). Doi: 10.1136/rmdopen-2022-002513

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Key clinical point: Axial psoriatic arthritis (PsA) can be categorized as a distinct subtype of PsA because it exhibits clinical and radiological symptoms that are different from those of ankylosing spondylitis (AS) with psoriasis.

Major finding: Compared with patients with AS and psoriasis, patients with human leukocyte antigen (HLA)-B27-negative axial PsA had lesser inflammatory pain (P = .002), anterior uveitis (P = .014), and structural damage (P < .001) along with a higher prevalence of nail disease (P = .009) and were more likely to present with psoriasis before spondyloarthritis onset (P = .020). However, patients with HLA-B27-positive axial PsA vs AS and psoriasis reported lesser structural damage as revealed by Bath Ankylosing Spondylitis Radiology Index scores (P < .001).

Study details: This cross-sectional study included 109 patients with axial PsA and 127 patients with AS and current presentation or a history of skin psoriasis from the REGISPONSER registry.

Disclosures: The REGISPONSER registry is funded by the Spanish Society for Rheumatology. The authors declared no conflicts of interest.

Source: Michelena X et al. Characterising the axial phenotype of psoriatic arthritis: a study comparing axial psoriatic arthritis and ankylosing spondylitis with psoriasis from the REGISPONSER registry. RMD Open. 2022;8:e002513 (Dec 5). Doi: 10.1136/rmdopen-2022-002513

Key clinical point: Axial psoriatic arthritis (PsA) can be categorized as a distinct subtype of PsA because it exhibits clinical and radiological symptoms that are different from those of ankylosing spondylitis (AS) with psoriasis.

Major finding: Compared with patients with AS and psoriasis, patients with human leukocyte antigen (HLA)-B27-negative axial PsA had lesser inflammatory pain (P = .002), anterior uveitis (P = .014), and structural damage (P < .001) along with a higher prevalence of nail disease (P = .009) and were more likely to present with psoriasis before spondyloarthritis onset (P = .020). However, patients with HLA-B27-positive axial PsA vs AS and psoriasis reported lesser structural damage as revealed by Bath Ankylosing Spondylitis Radiology Index scores (P < .001).

Study details: This cross-sectional study included 109 patients with axial PsA and 127 patients with AS and current presentation or a history of skin psoriasis from the REGISPONSER registry.

Disclosures: The REGISPONSER registry is funded by the Spanish Society for Rheumatology. The authors declared no conflicts of interest.

Source: Michelena X et al. Characterising the axial phenotype of psoriatic arthritis: a study comparing axial psoriatic arthritis and ankylosing spondylitis with psoriasis from the REGISPONSER registry. RMD Open. 2022;8:e002513 (Dec 5). Doi: 10.1136/rmdopen-2022-002513

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Effect of alcohol consumption and smoking on PsA manifestations

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Key clinical point: Smoking and alcohol consumption were associated with a lower prevalence of arthritis and peripheral manifestations in patients with psoriatic arthritis (PsA).

Major finding: Smoking was associated with a lower prevalence of arthritis ever (odds ratio [OR] 0.63; 95% CI 0.41-0.95), and current alcohol consumption was associated with a lower prevalence of current arthritis or enthesitis (OR 0.61; 95% CI 0.47-0.79), current arthritis alone (OR 0.69; 95% CI 0.53-0.90), and current enthesitis alone (OR 0.49; 95% CI, 0.34-0.71).

Study details: Findings are from a multinational, cross-sectional study including patients with axial spondyloarthritis (n = 2717), peripheral spondyloarthritis (n = 432), and PsA (n = 1032).

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

Source: Ladehesa-Pineda ML et al. Smoking and alcohol consumption are associated with peripheral musculoskeletal involvement in patients with spondyloarthritis (including psoriatic arthritis). Results from the ASAS-PerSpA study. Semin Arthritis Rheum. 2022;58:152146 (Nov 30). Doi: 10.1016/j.semarthrit.2022.152146

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Key clinical point: Smoking and alcohol consumption were associated with a lower prevalence of arthritis and peripheral manifestations in patients with psoriatic arthritis (PsA).

Major finding: Smoking was associated with a lower prevalence of arthritis ever (odds ratio [OR] 0.63; 95% CI 0.41-0.95), and current alcohol consumption was associated with a lower prevalence of current arthritis or enthesitis (OR 0.61; 95% CI 0.47-0.79), current arthritis alone (OR 0.69; 95% CI 0.53-0.90), and current enthesitis alone (OR 0.49; 95% CI, 0.34-0.71).

Study details: Findings are from a multinational, cross-sectional study including patients with axial spondyloarthritis (n = 2717), peripheral spondyloarthritis (n = 432), and PsA (n = 1032).

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

Source: Ladehesa-Pineda ML et al. Smoking and alcohol consumption are associated with peripheral musculoskeletal involvement in patients with spondyloarthritis (including psoriatic arthritis). Results from the ASAS-PerSpA study. Semin Arthritis Rheum. 2022;58:152146 (Nov 30). Doi: 10.1016/j.semarthrit.2022.152146

Key clinical point: Smoking and alcohol consumption were associated with a lower prevalence of arthritis and peripheral manifestations in patients with psoriatic arthritis (PsA).

Major finding: Smoking was associated with a lower prevalence of arthritis ever (odds ratio [OR] 0.63; 95% CI 0.41-0.95), and current alcohol consumption was associated with a lower prevalence of current arthritis or enthesitis (OR 0.61; 95% CI 0.47-0.79), current arthritis alone (OR 0.69; 95% CI 0.53-0.90), and current enthesitis alone (OR 0.49; 95% CI, 0.34-0.71).

Study details: Findings are from a multinational, cross-sectional study including patients with axial spondyloarthritis (n = 2717), peripheral spondyloarthritis (n = 432), and PsA (n = 1032).

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

Source: Ladehesa-Pineda ML et al. Smoking and alcohol consumption are associated with peripheral musculoskeletal involvement in patients with spondyloarthritis (including psoriatic arthritis). Results from the ASAS-PerSpA study. Semin Arthritis Rheum. 2022;58:152146 (Nov 30). Doi: 10.1016/j.semarthrit.2022.152146

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Cognitive function significantly altered in PsA

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Key clinical point: Cognitive abilities were altered in patients with psoriatic arthritis (PsA) compared with non-rheumatology reference individuals, with significant impairment in selective attention.

Major finding: Patients with PsA reported significant deficits in selective attention (mean difference [MD] −4.5), no effect on working memory (P = .662) and improvement in episodic short-term memory (MD 3.0; both P < .001) compared with matched reference subjects.

Study details: Findings are from a cross-sectional, exploratory study including 101 patients with axial spondyloarthritis, 117 patients with PsA, and matched non-rheumatology reference subjects without any diseases relevant to cognitive performance.

Disclosures: This study was funded by the RHADAR GbR, Germany. Some authors, including the lead author, declared receiving grants, consulting fees, speaker’s fees, travel support, honoraria, or advisory board support from several sources.

Source: Kleinert S et al. Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis. Rheumatol Int. 2022 (Nov 28). Doi: 10.1007/s00296-022-05248-4

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Key clinical point: Cognitive abilities were altered in patients with psoriatic arthritis (PsA) compared with non-rheumatology reference individuals, with significant impairment in selective attention.

Major finding: Patients with PsA reported significant deficits in selective attention (mean difference [MD] −4.5), no effect on working memory (P = .662) and improvement in episodic short-term memory (MD 3.0; both P < .001) compared with matched reference subjects.

Study details: Findings are from a cross-sectional, exploratory study including 101 patients with axial spondyloarthritis, 117 patients with PsA, and matched non-rheumatology reference subjects without any diseases relevant to cognitive performance.

Disclosures: This study was funded by the RHADAR GbR, Germany. Some authors, including the lead author, declared receiving grants, consulting fees, speaker’s fees, travel support, honoraria, or advisory board support from several sources.

Source: Kleinert S et al. Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis. Rheumatol Int. 2022 (Nov 28). Doi: 10.1007/s00296-022-05248-4

Key clinical point: Cognitive abilities were altered in patients with psoriatic arthritis (PsA) compared with non-rheumatology reference individuals, with significant impairment in selective attention.

Major finding: Patients with PsA reported significant deficits in selective attention (mean difference [MD] −4.5), no effect on working memory (P = .662) and improvement in episodic short-term memory (MD 3.0; both P < .001) compared with matched reference subjects.

Study details: Findings are from a cross-sectional, exploratory study including 101 patients with axial spondyloarthritis, 117 patients with PsA, and matched non-rheumatology reference subjects without any diseases relevant to cognitive performance.

Disclosures: This study was funded by the RHADAR GbR, Germany. Some authors, including the lead author, declared receiving grants, consulting fees, speaker’s fees, travel support, honoraria, or advisory board support from several sources.

Source: Kleinert S et al. Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis. Rheumatol Int. 2022 (Nov 28). Doi: 10.1007/s00296-022-05248-4

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Greater joint damage and higher disease activity increases risk for surgery in PsA

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Key clinical point: Increasing disease activity and joint damage were significant risk factors for requiring musculoskeletal (MSK) surgery in patients with psoriatic arthritis (PsA).

Major finding: A greater number of damaged joints (hazard ratio [HR] 1.032; P < .001), presence of nail lesions (HR 2.079; P < .006), higher health assessment questionnaire scores (HR 2.012; P < .001), an elevated erythrocyte sedimentation rate (HR 2.365; P = .017), a greater number of actively inflamed joints (HR 1.037; P = .007), and human leukocyte antigen-B*27 positivity (HR 2.217; P = .048) were associated with an increased risk for surgery.

Study details: Findings are from a longitudinal, observational cohort study including 1574 patients with PsA, of which 11.8% underwent ≥1 MSK surgery attributable to PsA.

Disclosures: This study was supported by the Krembil Foundation, Toronto. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Musculoskeletal surgery in psoriatic arthritis: Prevalence and risk factors. J Rheumatol. 2022 (Nov 15). Doi: 10.3899/jrheum.220908

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Key clinical point: Increasing disease activity and joint damage were significant risk factors for requiring musculoskeletal (MSK) surgery in patients with psoriatic arthritis (PsA).

Major finding: A greater number of damaged joints (hazard ratio [HR] 1.032; P < .001), presence of nail lesions (HR 2.079; P < .006), higher health assessment questionnaire scores (HR 2.012; P < .001), an elevated erythrocyte sedimentation rate (HR 2.365; P = .017), a greater number of actively inflamed joints (HR 1.037; P = .007), and human leukocyte antigen-B*27 positivity (HR 2.217; P = .048) were associated with an increased risk for surgery.

Study details: Findings are from a longitudinal, observational cohort study including 1574 patients with PsA, of which 11.8% underwent ≥1 MSK surgery attributable to PsA.

Disclosures: This study was supported by the Krembil Foundation, Toronto. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Musculoskeletal surgery in psoriatic arthritis: Prevalence and risk factors. J Rheumatol. 2022 (Nov 15). Doi: 10.3899/jrheum.220908

Key clinical point: Increasing disease activity and joint damage were significant risk factors for requiring musculoskeletal (MSK) surgery in patients with psoriatic arthritis (PsA).

Major finding: A greater number of damaged joints (hazard ratio [HR] 1.032; P < .001), presence of nail lesions (HR 2.079; P < .006), higher health assessment questionnaire scores (HR 2.012; P < .001), an elevated erythrocyte sedimentation rate (HR 2.365; P = .017), a greater number of actively inflamed joints (HR 1.037; P = .007), and human leukocyte antigen-B*27 positivity (HR 2.217; P = .048) were associated with an increased risk for surgery.

Study details: Findings are from a longitudinal, observational cohort study including 1574 patients with PsA, of which 11.8% underwent ≥1 MSK surgery attributable to PsA.

Disclosures: This study was supported by the Krembil Foundation, Toronto. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Musculoskeletal surgery in psoriatic arthritis: Prevalence and risk factors. J Rheumatol. 2022 (Nov 15). Doi: 10.3899/jrheum.220908

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Understanding the bidirectional causal link between Crohn’s disease and PsA

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Key clinical point: Psoriatic arthritis (PsA) was positively associated with Crohn’s disease and genetically predicted Crohn’s disease was associated with an increased risk for PsA, indicating a bidirectional causal relationship between the 2 diseases.

Major finding: PsA was associated with a 31.9% increased risk for Crohn’s disease (odds ratio [OR] 1.319; P < .001) and genetically predicted Crohn’s disease was linked to a 44.8% higher risk for PsA (OR 1.448; P = .001).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 4510 patients with psoriasis, 1637 patients with PsA, and 212,242 control individuals along with 657 patients with Crohn’s disease, 2251 patients with ulcerative colitis, and 210,300 control individuals.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Sun Y et al. The causal relationship between psoriasis, psoriatic arthritis, and inflammatory bowel diseases. Sci Rep. 2022;12:20526 (Nov 28). Doi: 10.1038/s41598-022-24872-5

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Key clinical point: Psoriatic arthritis (PsA) was positively associated with Crohn’s disease and genetically predicted Crohn’s disease was associated with an increased risk for PsA, indicating a bidirectional causal relationship between the 2 diseases.

Major finding: PsA was associated with a 31.9% increased risk for Crohn’s disease (odds ratio [OR] 1.319; P < .001) and genetically predicted Crohn’s disease was linked to a 44.8% higher risk for PsA (OR 1.448; P = .001).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 4510 patients with psoriasis, 1637 patients with PsA, and 212,242 control individuals along with 657 patients with Crohn’s disease, 2251 patients with ulcerative colitis, and 210,300 control individuals.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Sun Y et al. The causal relationship between psoriasis, psoriatic arthritis, and inflammatory bowel diseases. Sci Rep. 2022;12:20526 (Nov 28). Doi: 10.1038/s41598-022-24872-5

Key clinical point: Psoriatic arthritis (PsA) was positively associated with Crohn’s disease and genetically predicted Crohn’s disease was associated with an increased risk for PsA, indicating a bidirectional causal relationship between the 2 diseases.

Major finding: PsA was associated with a 31.9% increased risk for Crohn’s disease (odds ratio [OR] 1.319; P < .001) and genetically predicted Crohn’s disease was linked to a 44.8% higher risk for PsA (OR 1.448; P = .001).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 4510 patients with psoriasis, 1637 patients with PsA, and 212,242 control individuals along with 657 patients with Crohn’s disease, 2251 patients with ulcerative colitis, and 210,300 control individuals.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Sun Y et al. The causal relationship between psoriasis, psoriatic arthritis, and inflammatory bowel diseases. Sci Rep. 2022;12:20526 (Nov 28). Doi: 10.1038/s41598-022-24872-5

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Nailfold capillary abnormalities predict PsA in patients with psoriasis

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Key clinical point: Nailfold capillary abnormalities were more prevalent in patients with psoriatic arthritis (PsA) than in patients with psoriasis vulgaris (PsV) and predicted the development of PsA in patients with psoriasis.

Major finding: Nailfold bleeding (NFB; 84.5% vs 34.7%) and enlarged capillaries (100.0% vs 25.4%; both P < .0001) were more prevalent in patients with PsA vs PsV, with both NFB (hazard ratio [HR] 2.75; P = .004) and enlarged capillaries (HR 4.49; P < .0001) predicting the development of PsA in patients with PsV.

Study details: Findings are from a prospective cohort study including 236 patients with PsV and 213 patients with PsA.

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

Source: Fukasawa T et al. Utility of nailfold capillary assessment for predicting psoriatic arthritis based on a prospective observational cohort study. Rheumatology (Oxford). 2022 (Nov 28). Doi: 10.1093/rheumatology/keac664

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Key clinical point: Nailfold capillary abnormalities were more prevalent in patients with psoriatic arthritis (PsA) than in patients with psoriasis vulgaris (PsV) and predicted the development of PsA in patients with psoriasis.

Major finding: Nailfold bleeding (NFB; 84.5% vs 34.7%) and enlarged capillaries (100.0% vs 25.4%; both P < .0001) were more prevalent in patients with PsA vs PsV, with both NFB (hazard ratio [HR] 2.75; P = .004) and enlarged capillaries (HR 4.49; P < .0001) predicting the development of PsA in patients with PsV.

Study details: Findings are from a prospective cohort study including 236 patients with PsV and 213 patients with PsA.

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

Source: Fukasawa T et al. Utility of nailfold capillary assessment for predicting psoriatic arthritis based on a prospective observational cohort study. Rheumatology (Oxford). 2022 (Nov 28). Doi: 10.1093/rheumatology/keac664

Key clinical point: Nailfold capillary abnormalities were more prevalent in patients with psoriatic arthritis (PsA) than in patients with psoriasis vulgaris (PsV) and predicted the development of PsA in patients with psoriasis.

Major finding: Nailfold bleeding (NFB; 84.5% vs 34.7%) and enlarged capillaries (100.0% vs 25.4%; both P < .0001) were more prevalent in patients with PsA vs PsV, with both NFB (hazard ratio [HR] 2.75; P = .004) and enlarged capillaries (HR 4.49; P < .0001) predicting the development of PsA in patients with PsV.

Study details: Findings are from a prospective cohort study including 236 patients with PsV and 213 patients with PsA.

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

Source: Fukasawa T et al. Utility of nailfold capillary assessment for predicting psoriatic arthritis based on a prospective observational cohort study. Rheumatology (Oxford). 2022 (Nov 28). Doi: 10.1093/rheumatology/keac664

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Bimekizumab beneficial in PsA patients with inadequate response to or intolerance of TNFα inhibitors

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Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

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Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

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