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Showing 151 results for “Phase 3”.

September 2023

Guselkumab Modulates Differentially Expressed Genes in Blood of Patients with Psoriatic Arthritis: Results from Two Phase 3, Randomized, Placebo-Controlled Trials

ACR Open Rheumatol. 2023 doi: 10.1002/acr2.11589

Whole blood transcriptome profiling reveals differential gene expression in patients with active PsA from the DISCOVER-1 and DISCOVER-2 clinical studies in comparison with healthy controls.

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Efficacy of Tofacitinib on Enthesitis in Patients with Active Psoriatic Arthritis: Analysis of Pooled Data from Two Phase 3 Studies

Arthritis Res Ther. 2023 22;25(1):153 doi: 10.1186/s13075-023-03108-5

Post-hoc analysis of two tofacitinib phase three studies concludes that tofacitinib treatment resulted in improvements in enthesitis in patients with PsA, regardless of baseline location or severity.

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August 2023

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 3-year Results from the Open-Label Extension of the Randomised Controlled Phase 3 SELECT-PsA 2 Study

Clin Exp Rheumatol. 2023 doi: 10.55563/clinexprheumatol/8l7bbk. Epub ahead of print

Data from this open-label extension showed the efficacy of upadacitinib observed at 56 weeks was maintained through to 152 weeks in the treatment of patients with PsA. No cumulative adverse effects were observed, and no new safety signals were identified.

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Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients with Rheumatoid Arthritis Receiving Tofacitinib

J Rheumatol. 2023 doi 10.3899/jrheum.2023-0112 Epub ahead of print

High paraoxonase activity is associated with a significantly reduced risk of MACE and non-NMSC malignancies in white/European RA patients. The PON1 Q192R RR genotype had a significantly greater association with paraoxonase versus the QQ genotype, but had no significant association with MACE or non-NMSC malignancies.

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Filgotinib Modulates Inflammation-Associated Peripheral Blood Protein Biomarkers in Adults with Active Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate

Rheumatol Ther. 2023 doi 10.1007/s40744-023-00583-9 Epub ahead of print

This study by Tanaka, et al. shows that filgotinib reduces peripheral protein biomarkers associated with JAK/STAT signalling, inflammatory signalling, immune cell migration, and bone resorption in RA patients. Notably, filgotinib 200 mg significantly reduced IL-6, TNF, CXCL13 levels as early as Week 4.

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July 2023

Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis

Rheumatol Ther 2023; 10:679–91 doi 10.1007/s40744-023-00536-2

Upadacitinib significantly improved patient-reported outcomes in AxSpA patients with bDMARD-IR after 14 Weeks of treatment. There were notable improvements in disease activity, pain, fatigue, function, HRQoL, and work productivity.

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Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study

Rheumatol Ther. 2023 doi 10.1007/s40744-023-00556-y Epub ahead of print

Administration of IV-golimumab 2 mg/kg improves fatigue symptoms in axial spondylitis in a 52 Week study. At Week 16 of treatment, improvements in ASAS, ASDAS, BASDAI and SF-36 scores were observed at week 16 of treatment.

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Pain and Inflammation as Mediators of Tofacitinib Treatment Effect on Fatigue in Patients with Ankylosing Spondylitis: A Mediation Analysis

Rheumatol Ther. 2023 doi 10.1007/s40744-023-00570-0 Epub ahead of print

Kristensen, et al. used mediation modelling to show that tofacitinib indirectly improved fatigue symptoms via back pain and morning stiffness. This study was carried out using FACIT-F- and BASDAI Q1-based models to determine the relationship between these variables.

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Baricitinib in Juvenile Idiopathic Arthritis: An International, Phase 3, Randomised, Double-blind, Placebo-controlled, Withdrawal, Efficacy, and Safety Trial

Lancet. 2023 S0140-6736(23)00921-2 doi 10.1016/S0140-6736(23)00921-2 Epub ahead of print

Phase 3 trial of baricitinib demonstrates efficacy with acceptable safety profile in polyarticular and extended oligoarticular juvenile idiopathic arthritis, juvenile psoriatic arthritis and enthesitis-related arthritis.

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Post Hoc Analysis of Patients with Rheumatoid Arthritis Under Clinical Remission in Two Japanese Phase 3 Trials of Peficitinib Treatment (RAJ3 and RAJ4)

Mod Rheumatol. 2023 doi: 10.1093/mr/road059 Epub ahead of print

Pots hoc analysis of peficitinib phase 3 trials shows that continued treatment with peficitinib up to Week 52 is linked to improved remission rates in Asian patients with RA.

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