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1دورية أكاديمية
المؤلفون: Mease, Philip, Gladman, Dafna D, Merola, Joseph F, Nash, Peter, Grieve, Stacy, Laliman-Khara, Victor, Willems, Damon, Taieb, Vanessa, Prickett, Adam R, Coates, Laura C
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: ACR, MDA, PASI, bimekizumab, disease-modifying antirheumatic drugs, network meta-analysis, psoriatic arthritis, systematic literature review, washington, swedish, Orthopedics, Rheumatology, Sports Medicine
الوصف: OBJECTIVES: To understand the relative efficacy and safety of bimekizumab, a selective inhibitor of interleukin-17F in addition to IL-17A, vs other biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) for psoriatic arthritis (PsA) using network meta-analysis (NMA). METHODS: A systematic literature review (most recent update conducted on 01 January 2023) identified randomised controlled trials (RCTs) of b/tsDMARDs in PsA. Bayesian NMAs were conducted for efficacy outcomes at Weeks 12-24 for b/tsDMARD-naïve and tumour necrosis factor inhibitor (TNFi) -experienced (exp) patients. Safety at Weeks 12-24 was analysed in a mixed population. Odds ratios (ORs) and differences of mean change with the associated 95% credible interval (CrI) were calculated for the best-fitting models, and the surface under the cumulative ranking curve (SUCRA) values were calculated to determine relative rank. RESULTS: The NMA included 41 RCTs for 22 b/tsDMARDs. For minimal disease activity (MDA), bimekizumab ranked 1st in b/tsDMARD-naïve patients and 2nd in TNFi-exp patients. In b/tsDMARD-naïve patients, bimekizumab ranked 6th, 5th, and 3rd for American College of Rheumatology response (ACR)20/50/70, respectively. In TNFi-experienced patients, bimekizumab ranked 1st, 2nd, and 1st for ACR20/50/70, respectively. For Psoriasis Area and Severity Index [PASI]90/100, bimekizumab ranked 2nd and 1st in b/tsDMARD-naïve patients, respectively, and 1st and 2nd in TNFi-exp patients, respectively. Bimekizumab was comparable to b/tsDMARDs for serious adverse events. CONCLUSION: Bimekizumab ranked favourably among b/tsDMARDs for efficacy on joint, skin, and MDA outcomes, and showed comparable safety, suggesting it may be a beneficial treatment option for patients with PsA.
العلاقة: https://digitalcommons.providence.org/publications/8483Test; https://www.ncbi.nlm.nih.gov/pubmed/38218744Test
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2دورية أكاديمية
المؤلفون: Ritchlin, Christopher T, Coates, Laura C, McInnes, Iain B, Mease, Philip, Merola, Joseph F, Tanaka, Yoshiya, Asahina, Akihiko, Gossec, Laure, Gottlieb, Alice B, Warren, Richard B, Ink, Barbara, Bajracharya, Rajan, Shende, Vishvesh, Coarse, Jason, Landewé, Robert Bm
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, swedish neuro, arthritis, psoriatic, biological therapy, psoriatic arthritis, Humans, Treatment Outcome, Antirheumatic Agents, Adalimumab, Antibodies, Monoclonal, Psoriasis, Biological Products, Double-Blind Method, Severity of Illness Index, Neurosciences, Rheumatology
الوصف: OBJECTIVES: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy versus placebo (PBO) at Week 16 in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis (PsA). Here, we report long-term efficacy and safety to Week 52. METHODS: BE OPTIMAL comprised a 16-week, double-blind, PBO-controlled period, then 36 weeks treatment-blind. Patients were randomised 3:2:1 to subcutaneous BKZ 160 mg every 4 weeks, PBO with switch to BKZ at Week 16, or reference arm (adalimumab (ADA) 40 mg every 2 weeks). Efficacy outcomes included the American College of Rheumatology (ACR) response criteria 20/50/70, Psoriasis Area and Severity Index (PASI) 75/90/100 in patients with baseline psoriasis affecting ≥3% body surface area and minimal disease activity (MDA); non-responder imputation. RESULTS: ACR20/50/70, PASI75/90/100 and MDA responses were sustained with BKZ to Week 52, consistent with results observed at Week 16. Patients who switched to BKZ at Week 16 demonstrated improvements in efficacy with similar results to BKZ-randomised patients by Week 52.To Week 52, 555/702 (79.1%) patients had ≥1 treatment-emergent adverse event (TEAE) during BKZ treatment; 113/140 (80.7%) on ADA. On BKZ, 46 (6.6%) patients had serious TEAEs. 54 (7.7%) CONCLUSIONS: The efficacy of BKZ in bDMARD-naïve patients with PsA was sustained from Week 16 to Week 52. BKZ was well tolerated with no new safety signals observed. TRIAL REGISTRATION NUMBER: NCT03895203.
العلاقة: https://digitalcommons.providence.org/publications/7868Test; https://pubmed.ncbi.nlm.nih.gov/37696588Test/
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3دورية أكاديمية
المؤلفون: Mease, Philip J, Ogdie, Alexis, Tesser, John, Shiff, Natalie J, Lin, Iris, Chakravarty, Soumya D, Kelleman, Michael, Dodge, Rhiannon, McLean, Robert R, Broadwell, Aaron, Kavanaugh, Arthur, Merola, Joseph F
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, Orthopedics, Rheumatology
الوصف: INTRODUCTION: The aim of this work is to evaluate treatment persistence and clinical outcomes after 6 months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry. METHODS: Participants with PsA who initiated and persisted with on-label guselkumab use post-Food and Drug Administration (FDA) approval for active PsA (7/13/2020; subcutaneous 100 mg at weeks 0, 4, and every 8 weeks) at their 6-month follow-up visit (occurring through 3/31/2023) comprised the primary analysis population (On-Label Persisters). Hierarchical, multiplicity-controlled primary and secondary outcomes were mean (95% confidence interval) changes from baseline at 6 months in clinical Disease Activity Index for PsA (cDAPSA; primary), Physician Global Assessment (PGA) of arthritis and psoriasis (visual analog scale [VAS] 0-100), patient-reported pain (VAS 0-100), and percent body surface area with psoriasis (%BSA). Paired t tests determined changes that were statistically significantly different from 0 (α = 0.05). RESULTS: Among 114 patients who initiated on-label guselkumab and had eligible baseline and 6-month visits, 90 (78.9%) had persistent use. Among these On-Label Persisters at baseline, mean duration of PsA symptoms = 13.6 years; mean cDAPSA, PGA, and patient-reported pain = 22.0, 42.3, and 57.0, respectively; 94.4% had a history of psoriasis (mean BSA 7.6%); and 18.9% and 73.3%, respectively, previously received 1 or ≥ 2 biologic/targeted synthetic disease-modifying antirheumatic drugs. The mean change (improvement) in cDAPSA was - 5.4 (- 8.5, - 2.3; p < 0.001) at 6 months. Significant mean improvements in PGA (- 19.0 [- 24.2, - 13.8]), patient-reported pain (- 9.1 [- 14.4, - 3.8]), and %BSA (- 5.1 [- 7.6, - 2.7]) were also observed (all p < 0.001). CONCLUSIONS: In this real-world PsA population, generally characterized by longstanding, treatment-resistant, active disease at baseline, persistent guselkumab use in nearly 80% of ...
العلاقة: https://digitalcommons.providence.org/publications/7838Test; https://pubmed.ncbi.nlm.nih.gov/37597159Test
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4دورية أكاديمية
المؤلفون: Ng, Beverly Cheok Kuan, Jadon, Deepak, Adebajo, Adewale, Ayan, Gizem, Callis Duffin, Kristina, Chandran, Vinod, Coates, Laura C, D'Agostino, Maria Antonietta, de Vlam, Kurt, Deodhar, Atul, Eder, Lihi, Garg, Amit, Gladman, Dafna D, Goel, Niti, Gottlieb, Alice B, Husni, M Elaine, Katz, Arnon, Kavanaugh, Arthur, Lubrano, Ennio, Mease, Philip, Merola, Joseph F, Nash, Peter, Ogdie, Alexis, Pennington, Stephen R, Perez-Chada, Lourdes M, Proft, Fabian, Rosen, Cheryl F, Savage, Laura, Goldenstein-Schainberg, Claudia, Siebert, Stefan, Soriano, Enrique R, Steinkoenig, Ingrid, Tillett, William, Armstrong, April W, FitzGerald, Oliver
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, Orthopedics, Rheumatology, Sports Medicine
الوصف: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) leadership congregated for a strategic planning meeting before the 2022 GRAPPA annual meeting in New York, USA. Meeting aims were to review GRAPPA's performance in relation to its 2016 goals and identify successes and areas for further improvement, identify key GRAPPA priorities and activities for the next 5 years, and explore committee structures to best support these aims.
العلاقة: https://digitalcommons.providence.org/publications/7796Test; https://www.ncbi.nlm.nih.gov/pubmed/37527861Test
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5دورية أكاديمية
المؤلفون: Leung, Ying-Ying, Tillett, William, de Wit, Maarten, Orbai, Ana-Maria, Coates, Laura C, FitzGerald, Oliver, Helliwell, Philip S, Strand, Vibeke, Mease, Philip, Goel, Niti, Christensen, Robin, Merola, Joseph F, Lindsay, Christine A, Ogdie, Alexis, Gossec, Laure, Gladman, Dafna D
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, seattle, swedish, Rheumatology
الوصف: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) working group-comprising rheumatologists, dermatologists, methodologists, and patient research partners-provided updates at the GRAPPA 2022 annual meeting on its work to evaluate composite outcome measures for PsA. Ten composite outcome measures were considered. Initial steps were to define the population, the purpose of use, and the proposed pros and cons of the 10 candidate composite instruments for PsA. Preliminary Delphi exercises within the working group and GRAPPA stakeholders confirmed high priority for evaluating minimal disease activity (MDA); moderate priority for Disease Activity in PsA (DAPSA), American College of Rheumatology (ACR) response criteria, Psoriatic Arthritis Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), 3 visual analog scale (VAS), and 4VAS; and low priority for Disease Activity Score in 28 joints (DAS28), Psoriatic Arthritis Responder Criteria (PsARC), and Routine Assessment of Patient Index Data 3 (RAPID3). Further appraisal of candidate composite instruments is ongoing.
العلاقة: https://digitalcommons.psjhealth.org/publications/7672Test; https://pubmed.ncbi.nlm.nih.gov/37419621Test/
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6دورية أكاديمية
المؤلفون: McInnes, Iain B, Asahina, Akihiko, Coates, Laura C, Landewé, Robert, Merola, Joseph F, Ritchlin, Christopher T, Tanaka, Yoshiya, Gossec, Laure, Gottlieb, Alice B, Warren, Richard B, Ink, Barbara, Assudani, Deepak, Bajracharya, Rajan, Shende, Vishvesh, Coarse, Jason, Mease, Philip
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, Adult, Humans, Arthritis, Psoriatic, Adalimumab, Treatment Outcome, Antibodies, Monoclonal, Antirheumatic Agents, Double-Blind Method, Biological Products, Severity of Illness Index, Orthopedics, Pharmacy and Pharmaceutical Sciences, Rheumatology
الوصف: BACKGROUND: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs). METHODS: BE OPTIMAL was a 52-week, phase 3, multicentre, randomised, double-blind, placebo-controlled, active reference (adalimumab) trial done at 135 sites (hospitals, clinics, doctors' offices, and research centres) in 14 countries. Eligible patients were 18 years or older with a documented diagnosis of adult-onset psoriatic arthritis that met the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening. Participants were randomly assigned with an interactive-voice and web-response system on the basis of a predetermined randomisation schedule (3:2:1, stratified by region and bone erosion number at baseline) to bimekizumab 160 mg every 4 weeks, placebo every 2 weeks, or the reference group (adalimumab 40 mg every 2 weeks), all administered subcutaneously. At week 16, patients randomly assigned to placebo switched to bimekizumab 160 mg every 4 weeks. The primary endpoint was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 (non-responder imputation). Efficacy analyses included all patients who were randomly assigned (intention-to-treat population); the safety analysis set comprised patients who received one or more doses of treatment. Data are presented to week 24 (preplanned analysis). This trial is registered at ClinicalTrials.gov, NCT03895203. FINDINGS: Between April 3, 2019, and Oct 25, 2021, 1163 patients were screened and 852 were randomly assigned to bimekizumab (n=431), placebo (n=281), and reference (adalimumab; n=140) groups. At week 16, significantly more patients receiving bimekizumab (189 [44%] of 431) reached ACR50 response versus placebo (28 [10%] of 281; odds ratio 7·1 [95% CI 4·6-10·9], p INTERPRETATION: ...
العلاقة: https://digitalcommons.psjhealth.org/publications/6816Test; https://pubmed.ncbi.nlm.nih.gov/36493791Test
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7دورية أكاديمية
المؤلفون: Merola, Joseph F, Landewé, Robert, McInnes, Iain B, Mease, Philip, Ritchlin, Christopher T, Tanaka, Yoshiya, Asahina, Akihiko, Behrens, Frank, Gladman, Dafna D, Gossec, Laure, Gottlieb, Alice B, Thaçi, Diamant, Warren, Richard B, Ink, Barbara, Assudani, Deepak, Bajracharya, Rajan, Shende, Vishvesh, Coarse, Jason, Coates, Laura C
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, Adult, Humans, Arthritis, Psoriatic, Interleukin-17, Tumor Necrosis Factor-alpha, Treatment Outcome, Antibodies, Monoclonal, Immunologic Factors, Psoriasis, Double-Blind Method, Severity of Illness Index, Orthopedics, Pharmacy and Pharmaceutical Sciences, Rheumatology
الوصف: BACKGROUND: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors. METHODS: BE COMPLETE was a phase 3, multicentre, randomised, double-blind, placebo-controlled trial conducted across 92 sites (including hospitals, clinics, and research centres) in 11 countries (Australia, Canada, Czech Republic, Germany, Hungary, Italy, Japan, Poland, Russia, the UK, and the USA). Eligible patients were aged 18 years or older with adult-onset psoriatic arthritis (meeting the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening) with a history of inadequate response or intolerance to treatment with one or two TNFα inhibitors for either psoriatic arthritis or psoriasis. We stratified patients with active psoriatic arthritis by region and previous TNFα inhibitor use. Patients were randomly assigned (2:1) to receive subcutaneous bimekizumab 160 mg every 4 weeks or placebo by an interactive-voice and web-response system on the basis of a predetermined randomisation schedule. The primary endpoint was the proportion of patients with 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 (non-responder imputation). Efficacy analyses were done in the randomised population. The safety analysis set comprised patients who received one or more doses of study treatment. This trial was registered at ClinicalTrials.gov, NCT03896581, and is completed. FINDINGS: Between March 28, 2019, and Feb 14, 2022, 556 patients were screened and 400 patients were randomly assigned to bimekizumab 160 mg every 4 weeks (n=267) or placebo (n=133). The primary and all hierarchical secondary endpoints were met at week 16. 116 (43%) of 267 patients receiving bimekizumab reached ACR50, compared with nine (7%) of 133 patients ...
العلاقة: https://digitalcommons.psjhealth.org/publications/6817Test; https://pubmed.ncbi.nlm.nih.gov/36495881Test
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8دورية أكاديمية
المؤلفون: Coates, Laura C, Smolen, Josef S, Mease, Philip, Husni, M Elaine, Merola, Joseph F, Lespessailles, Eric, Kishimoto, Mitsumasa, Macpherson, Lisa, Bradley, Andrew J, Bolce, Rebecca, Helliwell, Philip S
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Arthritis, Psoriatic, Disease Progression, Humans, Severity of Illness Index, Treatment Outcome, Orthopedics, Rheumatology
الوصف: BACKGROUND/OBJECTIVE: The aim of this study was to evaluate relative performance of composite measures in psoriatic arthritis and assess the impact of structural damage and functional disability on outcomes during ixekizumab treatment. METHODS: Data from SPIRIT-P1 and SPIRIT-P2 were analysed to evaluate the effect of ixekizumab on achievement of low disease activity (LDA) and remission with the minimal disease activity (MDA) and very low disease activity (VLDA) composite, Disease Activity index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis Disease Activity Score, GRAppa Composite ScorE and modified Composite Psoriatic Disease Activity Index (mCPDAI). Performance was compared by quantifying residual symptom burden and the impact of structural damage and functional disability. RESULTS: Significantly more ixekizumab-treated patients achieved treatment targets at week 24 versus placebo assessed with all composites. More patients achieved targets assessed by mCPDAI and DAPSA than other composites. Residual disease activity was similar between composites, but residual high patient-reported outcomes (PROs) and functional disability were more frequent when assessed with mCPDAI and DAPSA. Achievement of treatment targets was reduced by high baseline levels of structural damage and functional disability. CONCLUSION: Residual disease activity was similar in patients achieving treatment targets assessed with all composites, but residual high PROs and functional disability were more common when assessed with mCPDAI and DAPSA, most likely due to the absence/attenuated functional assessment in these composites. High baseline levels of structural damage and functional disability attenuated response rates with all composites, affecting MDA/VLDA most prominently; LDA may be the most appropriate target in these patients. TRIAL REGISTRATION NUMBER: NCT01695239.
العلاقة: https://digitalcommons.psjhealth.org/publications/6758Test; https://pubmed.ncbi.nlm.nih.gov/36171019Test
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9دورية أكاديمية
المؤلفون: Mease, Philip J, Ogdie, Alexis, Chakravarty, Soumya D, Shiff, Natalie J, Lin, Iris, McLean, Robert R, Malley, Wendi, Spitzer, Rebecca L, Kavanaugh, Arthur, Merola, Joseph F
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, seattle, swedish, Orthopedics, Rheumatology
الوصف: BACKGROUND: The monoclonal antibody guselkumab is the first selective inhibitor of the interleukin-23 p19 subunit approved to treat adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). Given its recent approval for active PsA, data describing patients with PsA initiating guselkumab outside of clinical trials are limited. OBJECTIVE: This analysis describes characteristics of patients with rheumatologist-diagnosed PsA initiating guselkumab in the US-based, prospective, observational CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. METHODS: Demographics, lifestyle/disease characteristics, comorbidities, prior treatment, and disease activity were summarized for patients with PsA initiating guselkumab from registry inception through 30 September, 2021. RESULTS: Of 113 patients initiating guselkumab, the majority were female (63%), obese (67%), had psoriasis (89%), and initiated guselkumab as monotherapy (81%). Common comorbidities were hypertension (32%), depression (30%), and diabetes mellitus (26%). Mean tender (6.8) and swollen (2.0) joint counts, clinical Disease Activity Index for PsA score (19.1), and 57% of participants with ≥ 3% body surface area affected by psoriasis indicated moderate disease activity. Axial involvement was identified in 49% of patients. Median patient-reported pain and fatigue visual analog scale scores (0-100) were 60 and 59, respectively. Prior to guselkumab, 76% of patients had received two or more biologic disease-modifying antirheumatic drugs; the last therapy prior to guselkumab was a biologic disease-modifying antirheumatic drug in 81% of patients. CONCLUSIONS: Registry participants with PsA initiating guselkumab had active peripheral joint and skin disease, with substantial pain and fatigue; a considerable proportion had axial involvement. Future studies will evaluate the effectiveness of guselkumab in this population.
العلاقة: https://digitalcommons.psjhealth.org/publications/6601Test; https://pubmed.ncbi.nlm.nih.gov/36243860Test
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10دورية أكاديمية
المؤلفون: de Vlam, Kurt, Mease, Philip, Bushmakin, Andrew G, Fleischmann, Roy, Ogdie, Alexis, Azevedo, Valderilio F, Merola, Joseph F, Woolcott, John, Cappelleri, Joseph C, Fallon, Lara, Taylor, Peter C
المصدر: Articles, Abstracts, and Reports
مصطلحات موضوعية: washington, swedish, Inflammation, Pain, Psoriatic arthritis, Tofacitinib, Orthopedics, Rheumatology
الوصف: INTRODUCTION: Pain is a multidimensional factor and core domain of psoriatic arthritis (PsA). This analysis aimed to quantify the role of potential inflammation-associated outcomes on pain reduction in patients with PsA receiving tofacitinib, using mediation modeling. METHODS: Pooled data were from two phase 3 studies (OPAL Broaden and OPAL Beyond) of patients with active PsA treated with tofacitinib 5 mg twice daily or placebo. Mediation modeling was utilized to quantify the indirect effects (via Itch Severity Item [ISI], C-reactive protein [CRP] levels, swollen joint count [SJC], Psoriasis Area and Severity Index [PASI], and enthesitis [using Leeds Enthesitis Index]) and direct effects (representing all other factors) of tofacitinib treatment on pain improvement. RESULTS: The initial model showed that tofacitinib treatment affects pain, primarily indirectly, via ISI, CRP, SJC, PASI, and enthesitis (overall 84.0%; P = 0.0009), with 16.0% (P = 0.5274) attributable to the direct effect. The model was respecified to exclude SJC and PASI. Analysis of the final model revealed that 29.5% (P = 0.0579) of tofacitinib treatment effect on pain was attributable to the direct effect, and 70.5% (P < 0.0001) was attributable to the indirect effect. ISI, CRP, and enthesitis mediated 37.4% (P = 0.0002), 15.3% (P = 0.0107), and 17.8% (P = 0.0157) of the tofacitinib treatment effect on pain, respectively. CONCLUSIONS: The majority of the effect of tofacitinib on pain was collectively mediated by itch, CRP, and enthesitis, with itch being the primary mediator of treatment effect. TRIAL REGISTRATION: NCT01877668, NCT01882439. GRAPHICAL PLS.
العلاقة: https://digitalcommons.psjhealth.org/publications/6485Test; https://pubmed.ncbi.nlm.nih.gov/36076054Test/
