Psoriatic Arthritis

Key clinical point: Methotrexate (MTX)-related side effects were more prevalent in patients with psoriatic arthritis (PsA) vs rheumatoid arthritis (RA), whereas tumor necrosis factor inhibitor (TNFi)-related side effects were equally prevalent in patients with PsA and RA.

Major finding: In the first year, a higher proportion of patients with PsA vs RA reported MTX-related side effects (44.8% vs 29.4%), but similar proportions of patients with PsA (24.2%) and RA (22.8%) reported TNFi-related side effects. Patients with PsA vs RA were 1.8 times more likely to experience side effects with MTX (odds ratio 1.77; 95% CI 1.21-2.60).

Study details: Findings are from a retrospective cohort study including new initiators of MTX (PsA: n = 116 and RA: n = 4247) and TNFi (PsA: n = 124 and RA: n = 4361).

Disclosures: This study was funded by Amgen Inc. Two authors declared being employees or owning stocks in Amgen. The other authors declared receiving grants, funding, honoraria, or consulting fees from several sources, including Amgen.

Source: Ogdie A et al. Side effects of methotrexate and tumor necrosis factor inhibitors: Differences in tolerability among patients with psoriatic arthritis and rheumatoid arthritis. ACR Open Rheumatol. 2022 (Aug 15). Doi: 10.1002/acr2.11467

Key clinical point: Methotrexate (MTX)-related side effects were more prevalent in patients with psoriatic arthritis (PsA) vs rheumatoid arthritis (RA), whereas tumor necrosis factor inhibitor (TNFi)-related side effects were equally prevalent in patients with PsA and RA.

Major finding: In the first year, a higher proportion of patients with PsA vs RA reported MTX-related side effects (44.8% vs 29.4%), but similar proportions of patients with PsA (24.2%) and RA (22.8%) reported TNFi-related side effects. Patients with PsA vs RA were 1.8 times more likely to experience side effects with MTX (odds ratio 1.77; 95% CI 1.21-2.60).

Study details: Findings are from a retrospective cohort study including new initiators of MTX (PsA: n = 116 and RA: n = 4247) and TNFi (PsA: n = 124 and RA: n = 4361).

Disclosures: This study was funded by Amgen Inc. Two authors declared being employees or owning stocks in Amgen. The other authors declared receiving grants, funding, honoraria, or consulting fees from several sources, including Amgen.

Source: Ogdie A et al. Side effects of methotrexate and tumor necrosis factor inhibitors: Differences in tolerability among patients with psoriatic arthritis and rheumatoid arthritis. ACR Open Rheumatol. 2022 (Aug 15). Doi: 10.1002/acr2.11467

Key clinical point: Methotrexate (MTX)-related side effects were more prevalent in patients with psoriatic arthritis (PsA) vs rheumatoid arthritis (RA), whereas tumor necrosis factor inhibitor (TNFi)-related side effects were equally prevalent in patients with PsA and RA.

Major finding: In the first year, a higher proportion of patients with PsA vs RA reported MTX-related side effects (44.8% vs 29.4%), but similar proportions of patients with PsA (24.2%) and RA (22.8%) reported TNFi-related side effects. Patients with PsA vs RA were 1.8 times more likely to experience side effects with MTX (odds ratio 1.77; 95% CI 1.21-2.60).

Study details: Findings are from a retrospective cohort study including new initiators of MTX (PsA: n = 116 and RA: n = 4247) and TNFi (PsA: n = 124 and RA: n = 4361).

Disclosures: This study was funded by Amgen Inc. Two authors declared being employees or owning stocks in Amgen. The other authors declared receiving grants, funding, honoraria, or consulting fees from several sources, including Amgen.

Source: Ogdie A et al. Side effects of methotrexate and tumor necrosis factor inhibitors: Differences in tolerability among patients with psoriatic arthritis and rheumatoid arthritis. ACR Open Rheumatol. 2022 (Aug 15). Doi: 10.1002/acr2.11467

Key clinical point: Among patients with psoriatic arthritis (PsA) women experienced significantly higher disease burden than men despite similar disease activity and comparable treatments.

Major finding: Despite similar disease duration (P  =  .42), disease presentation, and biologic use (P  =  .38), women vs men had worse mean quality-of-life (0.80 vs 0.82; P  =  .02) and disability and physical functioning (0.56 vs 0.41; P < .01) scores, greater degree of work activity impairment (27.9% vs 24.6%; P < .01), and higher pain and fatigue scores (P < .01).

Study details: This study analyzed the data of 2270 patients with PsA (1223 men and 1047 women) from the Adelphi PsA Disease Specific Programme.

Disclosures: This study was funded by Janssen Research & Development, LLC. Three authors declared being employees of Janssen and owning stocks in Janssen/Johnson and Johnson. Some authors declared receiving research grants and consulting fees from several sources, including Janssen.

Source: Gossec L et al. Women with psoriatic arthritis experience higher disease burden than men: Findings from a real-world survey in the USA and Europe. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.220154

Key clinical point: Among patients with psoriatic arthritis (PsA) women experienced significantly higher disease burden than men despite similar disease activity and comparable treatments.

Major finding: Despite similar disease duration (P  =  .42), disease presentation, and biologic use (P  =  .38), women vs men had worse mean quality-of-life (0.80 vs 0.82; P  =  .02) and disability and physical functioning (0.56 vs 0.41; P < .01) scores, greater degree of work activity impairment (27.9% vs 24.6%; P < .01), and higher pain and fatigue scores (P < .01).

Study details: This study analyzed the data of 2270 patients with PsA (1223 men and 1047 women) from the Adelphi PsA Disease Specific Programme.

Disclosures: This study was funded by Janssen Research & Development, LLC. Three authors declared being employees of Janssen and owning stocks in Janssen/Johnson and Johnson. Some authors declared receiving research grants and consulting fees from several sources, including Janssen.

Source: Gossec L et al. Women with psoriatic arthritis experience higher disease burden than men: Findings from a real-world survey in the USA and Europe. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.220154

Key clinical point: Among patients with psoriatic arthritis (PsA) women experienced significantly higher disease burden than men despite similar disease activity and comparable treatments.

Major finding: Despite similar disease duration (P  =  .42), disease presentation, and biologic use (P  =  .38), women vs men had worse mean quality-of-life (0.80 vs 0.82; P  =  .02) and disability and physical functioning (0.56 vs 0.41; P < .01) scores, greater degree of work activity impairment (27.9% vs 24.6%; P < .01), and higher pain and fatigue scores (P < .01).

Study details: This study analyzed the data of 2270 patients with PsA (1223 men and 1047 women) from the Adelphi PsA Disease Specific Programme.

Disclosures: This study was funded by Janssen Research & Development, LLC. Three authors declared being employees of Janssen and owning stocks in Janssen/Johnson and Johnson. Some authors declared receiving research grants and consulting fees from several sources, including Janssen.

Source: Gossec L et al. Women with psoriatic arthritis experience higher disease burden than men: Findings from a real-world survey in the USA and Europe. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.220154

Key clinical point: Among patients with psoriatic arthritis (PsA) women experienced significantly higher disease burden than men despite similar disease activity and comparable treatments.

Major finding: Despite similar disease duration (P  =  .42), disease presentation, and biologic use (P  =  .38), women vs men had worse mean quality-of-life (0.80 vs 0.82; P  =  .02) and disability and physical functioning (0.56 vs 0.41; P < .01) scores, greater degree of work activity impairment (27.9% vs 24.6%; P < .01), and higher pain and fatigue scores (P < .01).

Study details: This study analyzed the data of 2270 patients with PsA (1223 men and 1047 women) from the Adelphi PsA Disease Specific Programme.

Disclosures: This study was funded by Janssen Research & Development, LLC. Three authors declared being employees of Janssen and owning stocks in Janssen/Johnson and Johnson. Some authors declared receiving research grants and consulting fees from several sources, including Janssen.

Source: Gossec L et al. Women with psoriatic arthritis experience higher disease burden than men: Findings from a real-world survey in the USA and Europe. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.220154

Key clinical point: Among patients with psoriatic arthritis (PsA) women experienced significantly higher disease burden than men despite similar disease activity and comparable treatments.

Major finding: Despite similar disease duration (P  =  .42), disease presentation, and biologic use (P  =  .38), women vs men had worse mean quality-of-life (0.80 vs 0.82; P  =  .02) and disability and physical functioning (0.56 vs 0.41; P < .01) scores, greater degree of work activity impairment (27.9% vs 24.6%; P < .01), and higher pain and fatigue scores (P < .01).

Study details: This study analyzed the data of 2270 patients with PsA (1223 men and 1047 women) from the Adelphi PsA Disease Specific Programme.

Disclosures: This study was funded by Janssen Research & Development, LLC. Three authors declared being employees of Janssen and owning stocks in Janssen/Johnson and Johnson. Some authors declared receiving research grants and consulting fees from several sources, including Janssen.

Source: Gossec L et al. Women with psoriatic arthritis experience higher disease burden than men: Findings from a real-world survey in the USA and Europe. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.220154

Key clinical point: Among patients with psoriatic arthritis (PsA) women experienced significantly higher disease burden than men despite similar disease activity and comparable treatments.

Major finding: Despite similar disease duration (P  =  .42), disease presentation, and biologic use (P  =  .38), women vs men had worse mean quality-of-life (0.80 vs 0.82; P  =  .02) and disability and physical functioning (0.56 vs 0.41; P < .01) scores, greater degree of work activity impairment (27.9% vs 24.6%; P < .01), and higher pain and fatigue scores (P < .01).

Study details: This study analyzed the data of 2270 patients with PsA (1223 men and 1047 women) from the Adelphi PsA Disease Specific Programme.

Disclosures: This study was funded by Janssen Research & Development, LLC. Three authors declared being employees of Janssen and owning stocks in Janssen/Johnson and Johnson. Some authors declared receiving research grants and consulting fees from several sources, including Janssen.

Source: Gossec L et al. Women with psoriatic arthritis experience higher disease burden than men: Findings from a real-world survey in the USA and Europe. J Rheumatol. 2022 (Aug 15). Doi: 10.3899/jrheum.220154

Key clinical point: Levels of C-reactive protein (CRP), a classic inflammatory marker, do not adequately reflect the level of disease activity (DA) in patients with psoriatic arthritis (PsA).

Major finding: CRP status was only associated with the erythrocyte sedimentation rate (odds ratio 1.04; P  =  .005) and not with any DA-related parameter. Among patients with normal CRP levels, a substantial proportion (45.9%) of patients were in non-minimal DA state, with 21.2% having moderate DA and 5.9% having high DA.

Study details: Findings are from a cross-sectional study including 128 patients with PsA, of which 66.4% had normal CRP levels (≤0.5 mg/dL) and the remaining had high CRP levels (>0.5 mg/dL).

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

Source: Gialouri CG et al. Normal C-reactive protein in active psoriatic arthritis: Results from real-world clinical practice. Ther Adv Musculoskelet Dis. 2022 (Sep 5). Doi: 10.1177/1759720X221122417

Key clinical point: Levels of C-reactive protein (CRP), a classic inflammatory marker, do not adequately reflect the level of disease activity (DA) in patients with psoriatic arthritis (PsA).

Major finding: CRP status was only associated with the erythrocyte sedimentation rate (odds ratio 1.04; P  =  .005) and not with any DA-related parameter. Among patients with normal CRP levels, a substantial proportion (45.9%) of patients were in non-minimal DA state, with 21.2% having moderate DA and 5.9% having high DA.

Study details: Findings are from a cross-sectional study including 128 patients with PsA, of which 66.4% had normal CRP levels (≤0.5 mg/dL) and the remaining had high CRP levels (>0.5 mg/dL).

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

Source: Gialouri CG et al. Normal C-reactive protein in active psoriatic arthritis: Results from real-world clinical practice. Ther Adv Musculoskelet Dis. 2022 (Sep 5). Doi: 10.1177/1759720X221122417

Key clinical point: Levels of C-reactive protein (CRP), a classic inflammatory marker, do not adequately reflect the level of disease activity (DA) in patients with psoriatic arthritis (PsA).

Major finding: CRP status was only associated with the erythrocyte sedimentation rate (odds ratio 1.04; P  =  .005) and not with any DA-related parameter. Among patients with normal CRP levels, a substantial proportion (45.9%) of patients were in non-minimal DA state, with 21.2% having moderate DA and 5.9% having high DA.

Study details: Findings are from a cross-sectional study including 128 patients with PsA, of which 66.4% had normal CRP levels (≤0.5 mg/dL) and the remaining had high CRP levels (>0.5 mg/dL).

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

Source: Gialouri CG et al. Normal C-reactive protein in active psoriatic arthritis: Results from real-world clinical practice. Ther Adv Musculoskelet Dis. 2022 (Sep 5). Doi: 10.1177/1759720X221122417

Key clinical point: Levels of C-reactive protein (CRP), a classic inflammatory marker, do not adequately reflect the level of disease activity (DA) in patients with psoriatic arthritis (PsA).

Major finding: CRP status was only associated with the erythrocyte sedimentation rate (odds ratio 1.04; P  =  .005) and not with any DA-related parameter. Among patients with normal CRP levels, a substantial proportion (45.9%) of patients were in non-minimal DA state, with 21.2% having moderate DA and 5.9% having high DA.

Study details: Findings are from a cross-sectional study including 128 patients with PsA, of which 66.4% had normal CRP levels (≤0.5mg/dL) and the remaining had high CRP levels (>0.5mg/dL).

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

Source: Gialouri CG et al. Normal C-reactive protein in active psoriatic arthritis: Results from real-world clinical practice. Ther Adv Musculoskelet Dis. 2022 (Sep 5). Doi: 10.1177/1759720X221122417

Key clinical point: Levels of C-reactive protein (CRP), a classic inflammatory marker, do not adequately reflect the level of disease activity (DA) in patients with psoriatic arthritis (PsA).

Major finding: CRP status was only associated with the erythrocyte sedimentation rate (odds ratio 1.04; P  =  .005) and not with any DA-related parameter. Among patients with normal CRP levels, a substantial proportion (45.9%) of patients were in non-minimal DA state, with 21.2% having moderate DA and 5.9% having high DA.

Study details: Findings are from a cross-sectional study including 128 patients with PsA, of which 66.4% had normal CRP levels (≤0.5mg/dL) and the remaining had high CRP levels (>0.5mg/dL).

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

Source: Gialouri CG et al. Normal C-reactive protein in active psoriatic arthritis: Results from real-world clinical practice. Ther Adv Musculoskelet Dis. 2022 (Sep 5). Doi: 10.1177/1759720X221122417

Key clinical point: Levels of C-reactive protein (CRP), a classic inflammatory marker, do not adequately reflect the level of disease activity (DA) in patients with psoriatic arthritis (PsA).

Major finding: CRP status was only associated with the erythrocyte sedimentation rate (odds ratio 1.04; P  =  .005) and not with any DA-related parameter. Among patients with normal CRP levels, a substantial proportion (45.9%) of patients were in non-minimal DA state, with 21.2% having moderate DA and 5.9% having high DA.

Study details: Findings are from a cross-sectional study including 128 patients with PsA, of which 66.4% had normal CRP levels (≤0.5mg/dL) and the remaining had high CRP levels (>0.5mg/dL).

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

Source: Gialouri CG et al. Normal C-reactive protein in active psoriatic arthritis: Results from real-world clinical practice. Ther Adv Musculoskelet Dis. 2022 (Sep 5). Doi: 10.1177/1759720X221122417

Key clinical point: Patients with active psoriatic arthritis (PsA) who received ustekinumab for 160 weeks showed rapid and sustained improvements in the signs and symptoms of PsA.

Major finding: A decrease in both tender joint count (TJC; 8.0 to 5.8) and swollen joint count (SJC; 4.5 to 3.1) was observed from baseline to week 4, with further decrease until week 28. Improvements were sustained up to week 160 (TJC 1.0; SJC 0.4). Minimal disease activity was achieved by 31.9% of patients at week 28 and 33.6% of patients at week 52.

Study details: Findings are from the prospective, non-interventional SUSTAIN study including 129 patients with active PsA and a previous inadequate response to disease-modifying antirheumatic drugs who were followed up to week 160.

Disclosures: The SUSTAIN study was funded by Janssen-Cilag GmbH. Three authors declared being employees of Janssen-Cilag GmbH and holding stocks in Johnson and Johnson, the parent company of Janssen. The other authors declared no conflicts of interest.

Source: Wendler J et al. Ustekinumab is rapid-acting and is an effective long-term treatment for patients with active psoriatic arthritis: Real-world evidence from the non-interventional SUSTAIN study. Rheumatol Ther. 2022 (Sep 6). Doi: 10.1007/s40744-022-00484-3

Key clinical point: Patients with active psoriatic arthritis (PsA) who received ustekinumab for 160 weeks showed rapid and sustained improvements in the signs and symptoms of PsA.

Major finding: A decrease in both tender joint count (TJC; 8.0 to 5.8) and swollen joint count (SJC; 4.5 to 3.1) was observed from baseline to week 4, with further decrease until week 28. Improvements were sustained up to week 160 (TJC 1.0; SJC 0.4). Minimal disease activity was achieved by 31.9% of patients at week 28 and 33.6% of patients at week 52.

Study details: Findings are from the prospective, non-interventional SUSTAIN study including 129 patients with active PsA and a previous inadequate response to disease-modifying antirheumatic drugs who were followed up to week 160.

Disclosures: The SUSTAIN study was funded by Janssen-Cilag GmbH. Three authors declared being employees of Janssen-Cilag GmbH and holding stocks in Johnson and Johnson, the parent company of Janssen. The other authors declared no conflicts of interest.

Source: Wendler J et al. Ustekinumab is rapid-acting and is an effective long-term treatment for patients with active psoriatic arthritis: Real-world evidence from the non-interventional SUSTAIN study. Rheumatol Ther. 2022 (Sep 6). Doi: 10.1007/s40744-022-00484-3

Key clinical point: Patients with active psoriatic arthritis (PsA) who received ustekinumab for 160 weeks showed rapid and sustained improvements in the signs and symptoms of PsA.

Major finding: A decrease in both tender joint count (TJC; 8.0 to 5.8) and swollen joint count (SJC; 4.5 to 3.1) was observed from baseline to week 4, with further decrease until week 28. Improvements were sustained up to week 160 (TJC 1.0; SJC 0.4). Minimal disease activity was achieved by 31.9% of patients at week 28 and 33.6% of patients at week 52.

Study details: Findings are from the prospective, non-interventional SUSTAIN study including 129 patients with active PsA and a previous inadequate response to disease-modifying antirheumatic drugs who were followed up to week 160.

Disclosures: The SUSTAIN study was funded by Janssen-Cilag GmbH. Three authors declared being employees of Janssen-Cilag GmbH and holding stocks in Johnson and Johnson, the parent company of Janssen. The other authors declared no conflicts of interest.

Source: Wendler J et al. Ustekinumab is rapid-acting and is an effective long-term treatment for patients with active psoriatic arthritis: Real-world evidence from the non-interventional SUSTAIN study. Rheumatol Ther. 2022 (Sep 6). Doi: 10.1007/s40744-022-00484-3

Key clinical point: Patients with isolated axial psoriatic arthritis (PsA) had a better functional status than those with both axial and peripheral disease. Human leucocyte antigen (HLA)-B*27 positivity was associated with isolated axial PsA and predicted the development of peripheral disease over time.

Major finding: Compared with patients with concomitant axial and peripheral disease, HLA-B*27 positivity (odds ratio [OR] 25.00; P < .003) and lower Health Assessment Questionnaire scores (OR 0.004; P < .01) were associated with isolated axial disease. HLA-B*27 positivity predicted the development of peripheral PsA in patients with isolated axial PsA (hazard ratio 7.544; P < .006).

Study details: Findings are from a longitudinal study including 1688 patients with ankylosing spondylitis and psoriasis and 1576 patients with PsA, of which 32 had isolated axial disease and 463 had axial with peripheral disease.

Disclosures: The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Isolated axial disease in psoriatic arthritis and ankylosing spondylitis with psoriasis. Ann Rheum Dis. 2022 (Aug 16). Doi: 10.1136/ard-2022-222537

Key clinical point: Patients with isolated axial psoriatic arthritis (PsA) had a better functional status than those with both axial and peripheral disease. Human leucocyte antigen (HLA)-B*27 positivity was associated with isolated axial PsA and predicted the development of peripheral disease over time.

Major finding: Compared with patients with concomitant axial and peripheral disease, HLA-B*27 positivity (odds ratio [OR] 25.00; P < .003) and lower Health Assessment Questionnaire scores (OR 0.004; P < .01) were associated with isolated axial disease. HLA-B*27 positivity predicted the development of peripheral PsA in patients with isolated axial PsA (hazard ratio 7.544; P < .006).

Study details: Findings are from a longitudinal study including 1688 patients with ankylosing spondylitis and psoriasis and 1576 patients with PsA, of which 32 had isolated axial disease and 463 had axial with peripheral disease.

Disclosures: The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Isolated axial disease in psoriatic arthritis and ankylosing spondylitis with psoriasis. Ann Rheum Dis. 2022 (Aug 16). Doi: 10.1136/ard-2022-222537

Key clinical point: Patients with isolated axial psoriatic arthritis (PsA) had a better functional status than those with both axial and peripheral disease. Human leucocyte antigen (HLA)-B*27 positivity was associated with isolated axial PsA and predicted the development of peripheral disease over time.

Major finding: Compared with patients with concomitant axial and peripheral disease, HLA-B*27 positivity (odds ratio [OR] 25.00; P < .003) and lower Health Assessment Questionnaire scores (OR 0.004; P < .01) were associated with isolated axial disease. HLA-B*27 positivity predicted the development of peripheral PsA in patients with isolated axial PsA (hazard ratio 7.544; P < .006).

Study details: Findings are from a longitudinal study including 1688 patients with ankylosing spondylitis and psoriasis and 1576 patients with PsA, of which 32 had isolated axial disease and 463 had axial with peripheral disease.

Disclosures: The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Isolated axial disease in psoriatic arthritis and ankylosing spondylitis with psoriasis. Ann Rheum Dis. 2022 (Aug 16). Doi: 10.1136/ard-2022-222537

Key clinical point: Secukinumab significantly delayed disease flare compared with placebo and showed a consistent safety profile in patients with juvenile psoriatic arthritis (JPsA).

Major finding: Secukinumab vs placebo was associated with a significant delay in disease flare (hazard ratio 0.15; P < .001) and a higher proportion of patients achieving juvenile idiopathic arthritis American College of Rheumatology 30 response at week 104 (86.7% vs 62.5%). No new safety concerns were observed.

Study details: Findings are from a treatment-withdrawal, phase 3 study including 86 biologic-naive patients with active enthesitis-related arthritis (n = 52) or JPsA (n = 34) who were randomly assigned to receive secukinumab or placebo for up to 104 weeks.

Disclosures: This study was sponsored by Novartis Pharma AG. Four authors declared being employees and shareholders of Novartis. The other authors reported ties with several sources, including Novartis.

Source: Brunner HI et al on behalf of Paediatric Rheumatology INternational Trials Organization (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: A randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Ann Rheum Dis. 2022 (Aug 12). Doi: 10.1136/ard-2022-222849

Key clinical point: Secukinumab significantly delayed disease flare compared with placebo and showed a consistent safety profile in patients with juvenile psoriatic arthritis (JPsA).

Major finding: Secukinumab vs placebo was associated with a significant delay in disease flare (hazard ratio 0.15; P < .001) and a higher proportion of patients achieving juvenile idiopathic arthritis American College of Rheumatology 30 response at week 104 (86.7% vs 62.5%). No new safety concerns were observed.

Study details: Findings are from a treatment-withdrawal, phase 3 study including 86 biologic-naive patients with active enthesitis-related arthritis (n = 52) or JPsA (n = 34) who were randomly assigned to receive secukinumab or placebo for up to 104 weeks.

Disclosures: This study was sponsored by Novartis Pharma AG. Four authors declared being employees and shareholders of Novartis. The other authors reported ties with several sources, including Novartis.

Source: Brunner HI et al on behalf of Paediatric Rheumatology INternational Trials Organization (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: A randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Ann Rheum Dis. 2022 (Aug 12). Doi: 10.1136/ard-2022-222849

Key clinical point: Secukinumab significantly delayed disease flare compared with placebo and showed a consistent safety profile in patients with juvenile psoriatic arthritis (JPsA).

Major finding: Secukinumab vs placebo was associated with a significant delay in disease flare (hazard ratio 0.15; P < .001) and a higher proportion of patients achieving juvenile idiopathic arthritis American College of Rheumatology 30 response at week 104 (86.7% vs 62.5%). No new safety concerns were observed.

Study details: Findings are from a treatment-withdrawal, phase 3 study including 86 biologic-naive patients with active enthesitis-related arthritis (n = 52) or JPsA (n = 34) who were randomly assigned to receive secukinumab or placebo for up to 104 weeks.

Disclosures: This study was sponsored by Novartis Pharma AG. Four authors declared being employees and shareholders of Novartis. The other authors reported ties with several sources, including Novartis.

Source: Brunner HI et al on behalf of Paediatric Rheumatology INternational Trials Organization (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: A randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Ann Rheum Dis. 2022 (Aug 12). Doi: 10.1136/ard-2022-222849

Patients with a rheumatic immune-mediated inflammatory disease (IMID) had worse outcomes, especially for mortality, after a myocardial infarction than those without an IMID, in a large propensity-matched analysis.

At a median of 2 years after their MI, Medicare beneficiaries with an IMID had adjusted risks that were:

• 15% higher for all-cause death (hazard ratio, 1.15);
• 12% higher for heart failure (HR, 1.12);
• 8% higher for recurrent MI (HR, 1.08); and
• 6% higher risk for coronary reintervention (HR, 1.06; P < .05 for all).

In addition, interventions known to improve outcomes in this context, such as coronary revascularization, were less common in patients with IMID.

“This could be because they usually are sicker and have more risk factors when they present, like kidney disease, so maybe they’re not eligible for the therapy. But by itself, it was surprising they’re not offered these interventions as common[ly] as people who don’t have the disease,” Amgad Mentias, MD, a clinical cardiologist at the Cleveland Clinic, said in an interview.

The study was published Sept. 14 in the Journal of the American Heart Association, with Dr. Mentias as senior author and Heba Wassif, MD, MPH, also with Cleveland Clinic, as first author.

IMIDs, such as rheumatoid arthritis, psoriasis, lupus, and inflammatory bowel disease, are known to be associated with significantly higher cardiovascular disease (CVD) risk due to a greater prevalence of traditional CVD risk factors and chronic systemic inflammation.

Certain disease-modifying agents may also increase patients’ cardiovascular risk. This has been a long-simmering issue for the arthritis and ulcerative colitis drug tofacitinib (Xeljanz, Xeljanz XR), resulting in an updated boxed warning in 2021.

Many of these patients also have joint disease, pain, and fatigue, which can limit physical activity, Dr. Mentias said. “So these small nuances of how to manage these patients, or balance between controlling the inflammation but also improv[ing] cardiac risk factors, is not an easy task.”

Evidence regarding post-MI events has been inconsistent and limited to smaller single-center studies, he said. After propensity-score matching, the present study included 59,820 patients with and 178,547 patients without rheumatic IMIDs followed for a maximum of 6 years.

They were drawn from a cohort of 1.6 million persons aged 65 or older in the Medicare Provider Analysis and Review (MedPAR) file who had been admitted for an MI between 2014 and 2019. Of these, 60,072 had a prior history of rheumatic IMIDs, most commonly rheumatoid arthritis (77.8%), followed by systemic lupus erythematosus (12.2%), psoriasis (5.1%), systemic sclerosis (2.8%), and myositis/dermatomyositis (1.8%).

Patients with an IMID were more often women; had a higher prevalence of valve disease, pulmonary hypertension, hypothyroidism, and anemia; and were more likely to present with non–ST-segment MI (NSTEMI).

Rates of coronary angiography (46.1% vs. 51.5%), percutaneous coronary intervention (31.6% vs. 33.6%), and coronary artery bypass grafting (7.7% vs. 10.7%) were significantly lower in patients with IMIDs who had NSTEMI, compared with patients without an IMID who had NSTEMI. Rates of these interventions were also lower in patients with IMIDs who presented with STEMI versus their peers without an IMID, at 78.2% vs. 80.7%, 70.2% vs. 71.5%, and 4.9% vs. 6.4%, respectively.

Dr. Mentias pointed out that the emerging subspecialty of cardiorheumatology is gaining traction, especially at large hospitals and academic centers, but that less than one-third of persons in the United States with an IMID are likely to be under the care of such specialists.

“It’s important before developing an MI to try and control the different risk factors and improve the risk profile for these patients as much as possible by both specialties, and then, after an unfortunate event like MI happens, it’s important to make sure we offer therapies and treatments that are known to improve outcomes,” he said.

Commenting for this article, Jon Tyler Giles, MD, a clinical researcher who focuses on cardiovascular diseases in rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York, said that “at least for rheumatoid arthritis, this is something that we already knew. People with rheumatic arthritis, when they have a heart attack, are less likely to get the standard kind of treatments and have worse outcomes. This is a little larger sample, but it’s not a surprise, not a surprise at all.”

He noted that the study could have answered questions regarding potential drivers, but “they didn’t dig down into any of the factors that were associated with the poorer outcomes in the patients with rheumatoid arthritis and lupus and scleroderma.”

Indeed, the investigators acknowledge that the study lacked information on coronary anatomy, duration and severity of the autoimmune disease, imaging data, and medications such as anti-inflammatory or immune-targeted therapies.

Dr. Giles highlighted several factors that can contribute to a poorer post-MI prognosis in patients with rheumatic diseases; these include frailty, being more hypercoaguable, increased rates of myocardial dysfunction and other heart and blood vessel diseases, and chronic treatment with steroids and nonsteroidal anti-inflammatory drugs that often interferes with anticoagulation after a MI or when putting in a stent. “So, there’s lot of moving parts, and not one single thing that is likely the answer.”

In addition, he said, “there’s always going to be a portion of these patients who, despite doing the best that we can with treatment, are going to have very severe disease. That may or may not be the subset of patients that did the worst, but likely they’re overrepresented in those patients.”

Finally, the inability to move the needle may lie with the lack of evidence-based screening and management guidelines for cardiovascular disease in any rheumatic disease, Dr. Giles observed. “There’s no guideline for us to use to decide who needs screening over and above what’s recommended for the general population, and then, even if you do screen, what do you do other than what you would normally?”

Rheumatologists are often reluctant to take up the cardiovascular screening side of things because visits are short, and a lot of that time is spent trying to manage the inflammatory components of a patient’s disease, he said. There’s also a barrier in getting some patients to add a cardiologist to the mix of physicians they already see, especially if they don’t have any symptoms.

“If someone has had an event, it’s a lot easier for people to be convinced to go see the cardiologist, obviously, but prior to having an event, the preventative side of things is something that often gets missed or goes to the wayside,” Dr. Giles said.

The study was partly funded by philanthropic gifts by the Haslam family, Bailey family, and Khouri family to the Cleveland Clinic for coauthor Dr. Milind Desai’s research. Dr. Desai is a consultant for Medtronic and Bristol Myers Squibb and serves on an executive steering committee of a BMS-sponsored trial. The remaining authors report having no relevant disclosures. Dr. Giles is a consultant on drug cardiovascular safety for Pfizer, AbbVie, and Eli Lilly.

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

Patients with a rheumatic immune-mediated inflammatory disease (IMID) had worse outcomes, especially for mortality, after a myocardial infarction than those without an IMID, in a large propensity-matched analysis.

At a median of 2 years after their MI, Medicare beneficiaries with an IMID had adjusted risks that were:

• 15% higher for all-cause death (hazard ratio, 1.15);
• 12% higher for heart failure (HR, 1.12);
• 8% higher for recurrent MI (HR, 1.08); and
• 6% higher risk for coronary reintervention (HR, 1.06; P < .05 for all).

In addition, interventions known to improve outcomes in this context, such as coronary revascularization, were less common in patients with IMID.

“This could be because they usually are sicker and have more risk factors when they present, like kidney disease, so maybe they’re not eligible for the therapy. But by itself, it was surprising they’re not offered these interventions as common[ly] as people who don’t have the disease,” Amgad Mentias, MD, a clinical cardiologist at the Cleveland Clinic, said in an interview.

The study was published Sept. 14 in the Journal of the American Heart Association, with Dr. Mentias as senior author and Heba Wassif, MD, MPH, also with Cleveland Clinic, as first author.

IMIDs, such as rheumatoid arthritis, psoriasis, lupus, and inflammatory bowel disease, are known to be associated with significantly higher cardiovascular disease (CVD) risk due to a greater prevalence of traditional CVD risk factors and chronic systemic inflammation.

Certain disease-modifying agents may also increase patients’ cardiovascular risk. This has been a long-simmering issue for the arthritis and ulcerative colitis drug tofacitinib (Xeljanz, Xeljanz XR), resulting in an updated boxed warning in 2021.

Many of these patients also have joint disease, pain, and fatigue, which can limit physical activity, Dr. Mentias said. “So these small nuances of how to manage these patients, or balance between controlling the inflammation but also improv[ing] cardiac risk factors, is not an easy task.”

Evidence regarding post-MI events has been inconsistent and limited to smaller single-center studies, he said. After propensity-score matching, the present study included 59,820 patients with and 178,547 patients without rheumatic IMIDs followed for a maximum of 6 years.

They were drawn from a cohort of 1.6 million persons aged 65 or older in the Medicare Provider Analysis and Review (MedPAR) file who had been admitted for an MI between 2014 and 2019. Of these, 60,072 had a prior history of rheumatic IMIDs, most commonly rheumatoid arthritis (77.8%), followed by systemic lupus erythematosus (12.2%), psoriasis (5.1%), systemic sclerosis (2.8%), and myositis/dermatomyositis (1.8%).

Patients with an IMID were more often women; had a higher prevalence of valve disease, pulmonary hypertension, hypothyroidism, and anemia; and were more likely to present with non–ST-segment MI (NSTEMI).

Rates of coronary angiography (46.1% vs. 51.5%), percutaneous coronary intervention (31.6% vs. 33.6%), and coronary artery bypass grafting (7.7% vs. 10.7%) were significantly lower in patients with IMIDs who had NSTEMI, compared with patients without an IMID who had NSTEMI. Rates of these interventions were also lower in patients with IMIDs who presented with STEMI versus their peers without an IMID, at 78.2% vs. 80.7%, 70.2% vs. 71.5%, and 4.9% vs. 6.4%, respectively.

Dr. Mentias pointed out that the emerging subspecialty of cardiorheumatology is gaining traction, especially at large hospitals and academic centers, but that less than one-third of persons in the United States with an IMID are likely to be under the care of such specialists.

“It’s important before developing an MI to try and control the different risk factors and improve the risk profile for these patients as much as possible by both specialties, and then, after an unfortunate event like MI happens, it’s important to make sure we offer therapies and treatments that are known to improve outcomes,” he said.

Commenting for this article, Jon Tyler Giles, MD, a clinical researcher who focuses on cardiovascular diseases in rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York, said that “at least for rheumatoid arthritis, this is something that we already knew. People with rheumatic arthritis, when they have a heart attack, are less likely to get the standard kind of treatments and have worse outcomes. This is a little larger sample, but it’s not a surprise, not a surprise at all.”

He noted that the study could have answered questions regarding potential drivers, but “they didn’t dig down into any of the factors that were associated with the poorer outcomes in the patients with rheumatoid arthritis and lupus and scleroderma.”

Indeed, the investigators acknowledge that the study lacked information on coronary anatomy, duration and severity of the autoimmune disease, imaging data, and medications such as anti-inflammatory or immune-targeted therapies.

Dr. Giles highlighted several factors that can contribute to a poorer post-MI prognosis in patients with rheumatic diseases; these include frailty, being more hypercoaguable, increased rates of myocardial dysfunction and other heart and blood vessel diseases, and chronic treatment with steroids and nonsteroidal anti-inflammatory drugs that often interferes with anticoagulation after a MI or when putting in a stent. “So, there’s lot of moving parts, and not one single thing that is likely the answer.”

In addition, he said, “there’s always going to be a portion of these patients who, despite doing the best that we can with treatment, are going to have very severe disease. That may or may not be the subset of patients that did the worst, but likely they’re overrepresented in those patients.”

Finally, the inability to move the needle may lie with the lack of evidence-based screening and management guidelines for cardiovascular disease in any rheumatic disease, Dr. Giles observed. “There’s no guideline for us to use to decide who needs screening over and above what’s recommended for the general population, and then, even if you do screen, what do you do other than what you would normally?”

Rheumatologists are often reluctant to take up the cardiovascular screening side of things because visits are short, and a lot of that time is spent trying to manage the inflammatory components of a patient’s disease, he said. There’s also a barrier in getting some patients to add a cardiologist to the mix of physicians they already see, especially if they don’t have any symptoms.

“If someone has had an event, it’s a lot easier for people to be convinced to go see the cardiologist, obviously, but prior to having an event, the preventative side of things is something that often gets missed or goes to the wayside,” Dr. Giles said.

The study was partly funded by philanthropic gifts by the Haslam family, Bailey family, and Khouri family to the Cleveland Clinic for coauthor Dr. Milind Desai’s research. Dr. Desai is a consultant for Medtronic and Bristol Myers Squibb and serves on an executive steering committee of a BMS-sponsored trial. The remaining authors report having no relevant disclosures. Dr. Giles is a consultant on drug cardiovascular safety for Pfizer, AbbVie, and Eli Lilly.

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

Patients with a rheumatic immune-mediated inflammatory disease (IMID) had worse outcomes, especially for mortality, after a myocardial infarction than those without an IMID, in a large propensity-matched analysis.

At a median of 2 years after their MI, Medicare beneficiaries with an IMID had adjusted risks that were:

• 15% higher for all-cause death (hazard ratio, 1.15);
• 12% higher for heart failure (HR, 1.12);
• 8% higher for recurrent MI (HR, 1.08); and
• 6% higher risk for coronary reintervention (HR, 1.06; P < .05 for all).

In addition, interventions known to improve outcomes in this context, such as coronary revascularization, were less common in patients with IMID.

“This could be because they usually are sicker and have more risk factors when they present, like kidney disease, so maybe they’re not eligible for the therapy. But by itself, it was surprising they’re not offered these interventions as common[ly] as people who don’t have the disease,” Amgad Mentias, MD, a clinical cardiologist at the Cleveland Clinic, said in an interview.

The study was published Sept. 14 in the Journal of the American Heart Association, with Dr. Mentias as senior author and Heba Wassif, MD, MPH, also with Cleveland Clinic, as first author.

IMIDs, such as rheumatoid arthritis, psoriasis, lupus, and inflammatory bowel disease, are known to be associated with significantly higher cardiovascular disease (CVD) risk due to a greater prevalence of traditional CVD risk factors and chronic systemic inflammation.

Certain disease-modifying agents may also increase patients’ cardiovascular risk. This has been a long-simmering issue for the arthritis and ulcerative colitis drug tofacitinib (Xeljanz, Xeljanz XR), resulting in an updated boxed warning in 2021.

Many of these patients also have joint disease, pain, and fatigue, which can limit physical activity, Dr. Mentias said. “So these small nuances of how to manage these patients, or balance between controlling the inflammation but also improv[ing] cardiac risk factors, is not an easy task.”

Evidence regarding post-MI events has been inconsistent and limited to smaller single-center studies, he said. After propensity-score matching, the present study included 59,820 patients with and 178,547 patients without rheumatic IMIDs followed for a maximum of 6 years.

They were drawn from a cohort of 1.6 million persons aged 65 or older in the Medicare Provider Analysis and Review (MedPAR) file who had been admitted for an MI between 2014 and 2019. Of these, 60,072 had a prior history of rheumatic IMIDs, most commonly rheumatoid arthritis (77.8%), followed by systemic lupus erythematosus (12.2%), psoriasis (5.1%), systemic sclerosis (2.8%), and myositis/dermatomyositis (1.8%).

Patients with an IMID were more often women; had a higher prevalence of valve disease, pulmonary hypertension, hypothyroidism, and anemia; and were more likely to present with non–ST-segment MI (NSTEMI).

Rates of coronary angiography (46.1% vs. 51.5%), percutaneous coronary intervention (31.6% vs. 33.6%), and coronary artery bypass grafting (7.7% vs. 10.7%) were significantly lower in patients with IMIDs who had NSTEMI, compared with patients without an IMID who had NSTEMI. Rates of these interventions were also lower in patients with IMIDs who presented with STEMI versus their peers without an IMID, at 78.2% vs. 80.7%, 70.2% vs. 71.5%, and 4.9% vs. 6.4%, respectively.

Dr. Mentias pointed out that the emerging subspecialty of cardiorheumatology is gaining traction, especially at large hospitals and academic centers, but that less than one-third of persons in the United States with an IMID are likely to be under the care of such specialists.

“It’s important before developing an MI to try and control the different risk factors and improve the risk profile for these patients as much as possible by both specialties, and then, after an unfortunate event like MI happens, it’s important to make sure we offer therapies and treatments that are known to improve outcomes,” he said.

Commenting for this article, Jon Tyler Giles, MD, a clinical researcher who focuses on cardiovascular diseases in rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York, said that “at least for rheumatoid arthritis, this is something that we already knew. People with rheumatic arthritis, when they have a heart attack, are less likely to get the standard kind of treatments and have worse outcomes. This is a little larger sample, but it’s not a surprise, not a surprise at all.”

He noted that the study could have answered questions regarding potential drivers, but “they didn’t dig down into any of the factors that were associated with the poorer outcomes in the patients with rheumatoid arthritis and lupus and scleroderma.”

Indeed, the investigators acknowledge that the study lacked information on coronary anatomy, duration and severity of the autoimmune disease, imaging data, and medications such as anti-inflammatory or immune-targeted therapies.

Dr. Giles highlighted several factors that can contribute to a poorer post-MI prognosis in patients with rheumatic diseases; these include frailty, being more hypercoaguable, increased rates of myocardial dysfunction and other heart and blood vessel diseases, and chronic treatment with steroids and nonsteroidal anti-inflammatory drugs that often interferes with anticoagulation after a MI or when putting in a stent. “So, there’s lot of moving parts, and not one single thing that is likely the answer.”

In addition, he said, “there’s always going to be a portion of these patients who, despite doing the best that we can with treatment, are going to have very severe disease. That may or may not be the subset of patients that did the worst, but likely they’re overrepresented in those patients.”

Finally, the inability to move the needle may lie with the lack of evidence-based screening and management guidelines for cardiovascular disease in any rheumatic disease, Dr. Giles observed. “There’s no guideline for us to use to decide who needs screening over and above what’s recommended for the general population, and then, even if you do screen, what do you do other than what you would normally?”

Rheumatologists are often reluctant to take up the cardiovascular screening side of things because visits are short, and a lot of that time is spent trying to manage the inflammatory components of a patient’s disease, he said. There’s also a barrier in getting some patients to add a cardiologist to the mix of physicians they already see, especially if they don’t have any symptoms.

“If someone has had an event, it’s a lot easier for people to be convinced to go see the cardiologist, obviously, but prior to having an event, the preventative side of things is something that often gets missed or goes to the wayside,” Dr. Giles said.

The study was partly funded by philanthropic gifts by the Haslam family, Bailey family, and Khouri family to the Cleveland Clinic for coauthor Dr. Milind Desai’s research. Dr. Desai is a consultant for Medtronic and Bristol Myers Squibb and serves on an executive steering committee of a BMS-sponsored trial. The remaining authors report having no relevant disclosures. Dr. Giles is a consultant on drug cardiovascular safety for Pfizer, AbbVie, and Eli Lilly.

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

MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.

As a once-daily drug, deucravacitinib has “the potential to be a treatment of choice and a new standard of care for patients who require systemic therapy for their moderate to severe plaque psoriasis,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.

Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.

One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.

The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.

When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.

The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).

There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.

The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.

In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.

In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.

Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.

In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.

The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.

“Patients now have a choice,” he said.

Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.

“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.

Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.

MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.

As a once-daily drug, deucravacitinib has “the potential to be a treatment of choice and a new standard of care for patients who require systemic therapy for their moderate to severe plaque psoriasis,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.

Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.

One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.

The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.

When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.

The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).

There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.

The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.

In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.

In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.

Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.

In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.

The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.

“Patients now have a choice,” he said.

Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.

“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.

Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.

MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.

As a once-daily drug, deucravacitinib has “the potential to be a treatment of choice and a new standard of care for patients who require systemic therapy for their moderate to severe plaque psoriasis,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.

Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.

One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.

The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.

When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.

The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).

There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.

The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.

In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.

In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.

Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.

In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.

The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.

“Patients now have a choice,” he said.

Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.

“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.

Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.