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TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis

Autor: M. Cole, C. Yap, C. Buckley, W. F. Ng, I. McInnes, A. Filer, S. Siebert, A. Pratt, J. D. Isaacs, D. D. Stocken

Publikováno v: Trials, Vol 22, Iss 1, Pp 1-10 (2021)

Abstract Background Adaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical complexity but uptake has been slow especially outside of cancer trials. TRAFIC is a multi-c

Externí odkaz: https://doaj.org/article/e288990549964c93a1c4b9c09a373ddf

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AB0888 Guselkumab Provides Sustained Improvements in Work Productivity and Daily Activity in Patients With Active Psoriatic Arthritis Through 2 Years of DISCOVER-2

Autor: J. Curtis, I. Mcinnes, P. Rahman, D. D. Gladman, F. Yang, S. Peterson, A. Kollmeier, N. Shiff, C. Han, M. Shawi, W. Tillett, P. J. Mease

Publikováno v: Annals of the Rheumatic Diseases. 81:1568-1569

BackgroundPsoriatic arthritis (PsA) impacts patients’ (pts) work productivity (WP) and daily activity.1 DISCOVER-2 (D2), a Phase 3 trial of the selective interleukin-23 p19-subunit inhibitor guselkumab (GUS) in biologic-naïve pts with PsA,2 demons

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5eb8a52504792f597a251c44da716d98
https://doi.org/10.1136/annrheumdis-2022-eular.1366

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AB0892 Targeted Safety Analyses of Guselkumab: Long-Term Results from Randomized Clinical Trials in Patients with Active Psoriatic Arthritis and Moderate to Severe Psoriasis

Autor: P. J. Mease, P. Foley, K. Reich, S. D. Chakravarty, M. Shawi, Y. W. Yang, M. Miller, A. Kollmeier, X. L. Xu, J. Yu, Y. Wang, S. Sheng, Y. You, I. Mcinnes

Publikováno v: Annals of the Rheumatic Diseases. 81:1572-1573

BackgroundGuselkumab (GUS) demonstrated efficacy and a favorable safety profile in active PsA in the Phase (Ph) 21 and Ph3 DISCOVER-1&2 trials2,3 and in moderate-to-severe plaque psoriasis (PsO) in the Ph3 VOYAGE-1&2 trials.4,5ObjectivesTo assess lon

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::275d048958672605168ca495a02c0888
https://doi.org/10.1136/annrheumdis-2022-eular.1495

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OP0024 DIFFERENTIATION BETWEEN IL-6 AND IL-17 PATHWAY INHIBITION IN RELATIONSHIP WITH CLINICAL OUTCOMES IN NON-BIOLOGICAL DMARD-IR AND BIOLOGICAL DMARD-IR PSORIATIC ARTHRITIS PATIENTS TREATED WITH UPADACITINIB IN SELECT-PsA 1 AND SELECT-PsA 2 STUDIES

Autor: F. Cai, T. Sornasse, M. Ruzek, Y. Fang, K. Kato, P. Wung, I. McInnes

Publikováno v: Annals of the Rheumatic Diseases. 81:17-18

BackgroundThe differential contribution of IL-6 and IL-17 pathways to the pathogenesis of psoriatic arthritis (PsA) is not fully understood. Upadacitinib (UPA), an oral JAK inhibitor, was more effective than placebo (PBO) in improving key clinical ma

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e88afa2583d2706401978fc87ce04663
https://doi.org/10.1136/annrheumdis-2022-eular.801

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POS1032 RISANKIZUMAB FOR ACTIVE PSORIATIC ARTHRITIS: INTEGRATED SUBGROUP ANALYSIS FROM 2 DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDIES (KEEPsAKE 1 AND KEEPsAKE 2)

Autor: J. F. Merola, K. Callis-Duffin, B. Padilla, Z. Xue, H. Photowala, B. Kaplan, I. Mcinnes

Publikováno v: Annals of the Rheumatic Diseases. 81:829-830

BackgroundRisankizumab (RZB), a monoclonal antibody that specifically inhibits interleukin 23, is being investigated as a treatment for adults with psoriatic arthritis (PsA).ObjectivesWe report the proportion of patients with active PsA treated with

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c31c014768abf8875cec8e46c7d979c9
https://doi.org/10.1136/annrheumdis-2022-eular.1390

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POS1015 SAFETY OF GUSELKUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS WHO ARE BIO-NAÏVE OR TNFi-EXPERIENCED: POOLED RESULTS FROM 4 RANDOMIZED CLINICAL TRIALS THROUGH 2 YEARS

Autor: P. Rahman, W. H. Boehncke, P. J. Mease, A. B. Gottlieb, I. Mcinnes, M. Neuhold, M. Shawi, Y. Wang, S. Sheng, P. Bergmans, A. Kollmeier, E. Theander, J. Yu, E. Leibowitz, M. Marrache, L. Coates

Publikováno v: Annals of the Rheumatic Diseases. 81:816-817

BackgroundGuselkumab (GUS), a selective IL-23p19 subunit inhibitor, demonstrated efficacy and a favorable safety profile in active psoriatic arthritis (PsA) in the Phase (Ph)21, Ph3 (DISCOVER [D]-1&2)2,3, and Ph3b COSMOS4 randomized controlled trials

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ce770236f47ffce5cfdcb99e6acf235e
https://doi.org/10.1136/annrheumdis-2022-eular.219

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POS1028 GUSELKUMAB MAINTAINS RESOLUTION OF DACTYLITIS AND ENTHESITIS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS THROUGH 2 YEARS FROM A PHASE 3 STUDY

Autor: P. Rahman, I. Mcinnes, A. Deodhar, G. Schett, P. J. Mease, M. Shawi, D. Cua, J. Sherlock, A. Kollmeier, X. L. Xu, Y. Jiang, S. Sheng, C. T. Ritchlin, D. Mcgonagle

Publikováno v: Annals of the Rheumatic Diseases. 81:826-827

BackgroundGuselkumab (GUS), a selective inhibitor of IL-23, significantly improved the diverse manifestations of active psoriatic arthritis (PsA), including dactylitis and enthesitis, in DISCOVER (D)-1 & 2 trials of patients (pts) with active PsA1,2,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::1c8c483de18ac74b7f24374754a081a2
https://doi.org/10.1136/annrheumdis-2022-eular.1337

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