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Large integrated safety analysis reinforces known safety profile of ixekizumab in PsA

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Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.

Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.

Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi:  10.1136/annrheumdis-2021-222027

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Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.

Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.

Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi:  10.1136/annrheumdis-2021-222027

Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.

Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.

Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi:  10.1136/annrheumdis-2021-222027

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Multimodal imaging of DIP-joint and SEC can help distinguish PsA from psoriasis or OA

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Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

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Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

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Factors associated with increased sleep disturbance in PsA

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Key clinical point: Sleep disturbance was more prevalent in patients with psoriatic arthritis (PsA) than in those with psoriasis or healthy controls (HC) without inflammatory illnesses and was associated with various inflammatory and noninflammatory variables.

Major finding: Sleep disturbances were reported by 66.1% of patients with PsA vs. 45.0% of patients with psoriasis, and 15.0% of HC. Poor quality sleep was associated with tender points (P = .017), pain (P = .009), and global health scores (P = .005) and could not be resolved by immunosuppressive medical therapy.

Study details: This cross-sectional study included 109 patients with PsA who initiated or switched treatment with conventional synthetic or biological disease-modifying antirheumatic drugs, 20 patients with psoriasis, and 20 HC.

Disclosures: This study was supported by the Elisabeth and Karl Ejnar Nis-Hanssens Mindelegat, Minister Erna Hamiltons Legat for Videnskab og Kunst, and Oak Foundation. Some authors declared serving as consultants, investigators, or speakers, or receiving fees, honoraria, and research funding from several sources. JG Gerwien declared being an employee and stakeholder of Eli Lilly.

Source: Skougaard M et al. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2022 (Mar 18). Doi: 10.1080/03009742.2022.2044116

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Key clinical point: Sleep disturbance was more prevalent in patients with psoriatic arthritis (PsA) than in those with psoriasis or healthy controls (HC) without inflammatory illnesses and was associated with various inflammatory and noninflammatory variables.

Major finding: Sleep disturbances were reported by 66.1% of patients with PsA vs. 45.0% of patients with psoriasis, and 15.0% of HC. Poor quality sleep was associated with tender points (P = .017), pain (P = .009), and global health scores (P = .005) and could not be resolved by immunosuppressive medical therapy.

Study details: This cross-sectional study included 109 patients with PsA who initiated or switched treatment with conventional synthetic or biological disease-modifying antirheumatic drugs, 20 patients with psoriasis, and 20 HC.

Disclosures: This study was supported by the Elisabeth and Karl Ejnar Nis-Hanssens Mindelegat, Minister Erna Hamiltons Legat for Videnskab og Kunst, and Oak Foundation. Some authors declared serving as consultants, investigators, or speakers, or receiving fees, honoraria, and research funding from several sources. JG Gerwien declared being an employee and stakeholder of Eli Lilly.

Source: Skougaard M et al. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2022 (Mar 18). Doi: 10.1080/03009742.2022.2044116

Key clinical point: Sleep disturbance was more prevalent in patients with psoriatic arthritis (PsA) than in those with psoriasis or healthy controls (HC) without inflammatory illnesses and was associated with various inflammatory and noninflammatory variables.

Major finding: Sleep disturbances were reported by 66.1% of patients with PsA vs. 45.0% of patients with psoriasis, and 15.0% of HC. Poor quality sleep was associated with tender points (P = .017), pain (P = .009), and global health scores (P = .005) and could not be resolved by immunosuppressive medical therapy.

Study details: This cross-sectional study included 109 patients with PsA who initiated or switched treatment with conventional synthetic or biological disease-modifying antirheumatic drugs, 20 patients with psoriasis, and 20 HC.

Disclosures: This study was supported by the Elisabeth and Karl Ejnar Nis-Hanssens Mindelegat, Minister Erna Hamiltons Legat for Videnskab og Kunst, and Oak Foundation. Some authors declared serving as consultants, investigators, or speakers, or receiving fees, honoraria, and research funding from several sources. JG Gerwien declared being an employee and stakeholder of Eli Lilly.

Source: Skougaard M et al. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2022 (Mar 18). Doi: 10.1080/03009742.2022.2044116

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Differential response to ixekizumab among males and females with PsA

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Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.

Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).

Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w

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Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.

Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).

Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w

Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.

Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).

Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w

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Dermatological improvements translate to enhanced QoL in PsA

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Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.

Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.

Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924

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Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.

Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.

Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924

Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.

Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.

Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924

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PsA: Rapid and sustained improvement in pain with upadacitinib

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Key clinical point: Upadacitinib led to early, clinically meaningful, and sustained improvements in pain in patients with psoriatic arthritis (PsA) and an inadequate response to prior biological or nonbiological disease-modifying antirheumatic drugs (b/nbDMARD).

Major finding: A significantly higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as at 2 weeks (P < .05), with improvements sustained till week 56.

Study details: Findings are from an analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 , including 1113 patients with active PsA and an inadequate response to ≥1 nb/bDMARD who were randomly assigned to receive 15 mg upadacitinib once daily, placebo, or adalimumab (only in the SELECT-PsA 1 study).

Disclosures: This study was sponsored by AbbVie. Eight authors declared serving as employees or owning stock/stock options in AbbVie and other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: Post hoc analysis of three randomised clinical trials. RMD Open. 2022;8:e002049 (Mar 24). Doi: 10.1136/rmdopen-2021-002049

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Key clinical point: Upadacitinib led to early, clinically meaningful, and sustained improvements in pain in patients with psoriatic arthritis (PsA) and an inadequate response to prior biological or nonbiological disease-modifying antirheumatic drugs (b/nbDMARD).

Major finding: A significantly higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as at 2 weeks (P < .05), with improvements sustained till week 56.

Study details: Findings are from an analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 , including 1113 patients with active PsA and an inadequate response to ≥1 nb/bDMARD who were randomly assigned to receive 15 mg upadacitinib once daily, placebo, or adalimumab (only in the SELECT-PsA 1 study).

Disclosures: This study was sponsored by AbbVie. Eight authors declared serving as employees or owning stock/stock options in AbbVie and other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: Post hoc analysis of three randomised clinical trials. RMD Open. 2022;8:e002049 (Mar 24). Doi: 10.1136/rmdopen-2021-002049

Key clinical point: Upadacitinib led to early, clinically meaningful, and sustained improvements in pain in patients with psoriatic arthritis (PsA) and an inadequate response to prior biological or nonbiological disease-modifying antirheumatic drugs (b/nbDMARD).

Major finding: A significantly higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as at 2 weeks (P < .05), with improvements sustained till week 56.

Study details: Findings are from an analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 , including 1113 patients with active PsA and an inadequate response to ≥1 nb/bDMARD who were randomly assigned to receive 15 mg upadacitinib once daily, placebo, or adalimumab (only in the SELECT-PsA 1 study).

Disclosures: This study was sponsored by AbbVie. Eight authors declared serving as employees or owning stock/stock options in AbbVie and other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: Post hoc analysis of three randomised clinical trials. RMD Open. 2022;8:e002049 (Mar 24). Doi: 10.1136/rmdopen-2021-002049

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Robust and sustained improvement with guselkumab in a diverse population of patients with PsA

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Key clinical point: A dose of 100 mg guselkumab every 4 weeks (Q4W) or 8 weeks (Q8W) effectively improved the signs and symptoms of psoriatic arthritis (PsA) at week 24, with effects sustained till week 52, in subgroups of patients with diverse baseline characteristics.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W (62%/60%) vs. placebo (29%) achieved ≥20% improvement in the American College of Rheumatology (ACR20) criteria, with guselkumab demonstrating superior efficacy over placebo regardless of baseline patient demographics, disease characteristics, or medication use, with effects sustained till week 52.

Study details: This post hoc analysis of two phase 3 trials, DISCOVER-1, and DISCOVER-2, and included 1120 patients with active PsA with an inadequate response to standard therapies who were randomly assigned to receive subcutaneous 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owned stocks in Johnson & Johnson, the parent of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Ritchlin CT et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: Pooled results through week 52 of two phase III, randomised, placebo-controlled studies.  RMD Open. 2022;8:e002195 (Mar 16). Doi: 10.1136/rmdopen-2022-002195

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Key clinical point: A dose of 100 mg guselkumab every 4 weeks (Q4W) or 8 weeks (Q8W) effectively improved the signs and symptoms of psoriatic arthritis (PsA) at week 24, with effects sustained till week 52, in subgroups of patients with diverse baseline characteristics.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W (62%/60%) vs. placebo (29%) achieved ≥20% improvement in the American College of Rheumatology (ACR20) criteria, with guselkumab demonstrating superior efficacy over placebo regardless of baseline patient demographics, disease characteristics, or medication use, with effects sustained till week 52.

Study details: This post hoc analysis of two phase 3 trials, DISCOVER-1, and DISCOVER-2, and included 1120 patients with active PsA with an inadequate response to standard therapies who were randomly assigned to receive subcutaneous 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owned stocks in Johnson & Johnson, the parent of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Ritchlin CT et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: Pooled results through week 52 of two phase III, randomised, placebo-controlled studies.  RMD Open. 2022;8:e002195 (Mar 16). Doi: 10.1136/rmdopen-2022-002195

Key clinical point: A dose of 100 mg guselkumab every 4 weeks (Q4W) or 8 weeks (Q8W) effectively improved the signs and symptoms of psoriatic arthritis (PsA) at week 24, with effects sustained till week 52, in subgroups of patients with diverse baseline characteristics.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W (62%/60%) vs. placebo (29%) achieved ≥20% improvement in the American College of Rheumatology (ACR20) criteria, with guselkumab demonstrating superior efficacy over placebo regardless of baseline patient demographics, disease characteristics, or medication use, with effects sustained till week 52.

Study details: This post hoc analysis of two phase 3 trials, DISCOVER-1, and DISCOVER-2, and included 1120 patients with active PsA with an inadequate response to standard therapies who were randomly assigned to receive subcutaneous 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owned stocks in Johnson & Johnson, the parent of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Ritchlin CT et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: Pooled results through week 52 of two phase III, randomised, placebo-controlled studies.  RMD Open. 2022;8:e002195 (Mar 16). Doi: 10.1136/rmdopen-2022-002195

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IL-17 inhibitors associated with higher treatment persistence in PsA

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Key clinical point: Interleukin-17 (IL-17) inhibitors were associated with higher treatment persistence than tumor necrosis factor (TNF) inhibitors or IL-12/23 inhibitors in patients with psoriatic arthritis (PsA) who initiated treatment with biologics.

Major finding: Treatment persistence was higher with IL-17 inhibitors than TNF inhibitors (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23 inhibitor (weighted HR 0.69; P < .001); however, IL-12/23 and TNF inhibitors showed similar persistence (P = .70).

Study details: This nationwide cohort study included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with TNF, IL-12/23, or IL-17 inhibitors.

Disclosures: The study did not report any source of funding. P Claudepierre reported receiving consulting fees and serving as an investigator for several pharmaceutical companies.

Source: Vegas LP et al. Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the french health insurance database. JAMA Dermatol. 2022 (Mar 23). Doi: 10.1001/jamadermatol.2022.0364

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Key clinical point: Interleukin-17 (IL-17) inhibitors were associated with higher treatment persistence than tumor necrosis factor (TNF) inhibitors or IL-12/23 inhibitors in patients with psoriatic arthritis (PsA) who initiated treatment with biologics.

Major finding: Treatment persistence was higher with IL-17 inhibitors than TNF inhibitors (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23 inhibitor (weighted HR 0.69; P < .001); however, IL-12/23 and TNF inhibitors showed similar persistence (P = .70).

Study details: This nationwide cohort study included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with TNF, IL-12/23, or IL-17 inhibitors.

Disclosures: The study did not report any source of funding. P Claudepierre reported receiving consulting fees and serving as an investigator for several pharmaceutical companies.

Source: Vegas LP et al. Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the french health insurance database. JAMA Dermatol. 2022 (Mar 23). Doi: 10.1001/jamadermatol.2022.0364

Key clinical point: Interleukin-17 (IL-17) inhibitors were associated with higher treatment persistence than tumor necrosis factor (TNF) inhibitors or IL-12/23 inhibitors in patients with psoriatic arthritis (PsA) who initiated treatment with biologics.

Major finding: Treatment persistence was higher with IL-17 inhibitors than TNF inhibitors (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23 inhibitor (weighted HR 0.69; P < .001); however, IL-12/23 and TNF inhibitors showed similar persistence (P = .70).

Study details: This nationwide cohort study included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with TNF, IL-12/23, or IL-17 inhibitors.

Disclosures: The study did not report any source of funding. P Claudepierre reported receiving consulting fees and serving as an investigator for several pharmaceutical companies.

Source: Vegas LP et al. Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the french health insurance database. JAMA Dermatol. 2022 (Mar 23). Doi: 10.1001/jamadermatol.2022.0364

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Hypocaloric diet controls joint activity in psoriatic arthritis – regardless of weight loss

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A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

  • Diet-placebo (hypocaloric diet plus placebo supplementation).
  • Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
  • Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

  • The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
  • Minimal disease activity improved in all groups.
  • The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

  • No significant correlation was seen between weight loss and disease activity improvement.
  • Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
  • Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

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A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

  • Diet-placebo (hypocaloric diet plus placebo supplementation).
  • Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
  • Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

  • The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
  • Minimal disease activity improved in all groups.
  • The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

  • No significant correlation was seen between weight loss and disease activity improvement.
  • Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
  • Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

  • Diet-placebo (hypocaloric diet plus placebo supplementation).
  • Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
  • Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

  • The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
  • Minimal disease activity improved in all groups.
  • The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

  • No significant correlation was seen between weight loss and disease activity improvement.
  • Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
  • Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

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Psoriatic Arthritis Workup

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