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Showing 129 results for “Phase 3”.

Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study

Rheumatol Ther. 2022 Oct 15:1–18 doi: 10.1007/s40744-022-00499-w

Results from the long-term extension of SELECT-PsA 1 show efficacy responses similar or greater with upadacitinib, 15 or 30mg, versus adalimumab through 104 weeks.

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The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Adv Ther. 2022 Oct;39(10):4632-4644 doi: 10.1007/s12325-022-02269-0

In the latest study by Curtis, et al. guselkumab treatment regimens improved general HRQoL as measured by the EQ-5D-5L Index and EQ-VAS. In reaching this conclusion investigators aimed to determine the minimal important difference for both instruments and to understand the associations between patient-reported EQ-5D-5L Index and EQ-VAS scores as well as key PsA clinical features.

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Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis

N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302

Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.

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Upadacitinib for the Treatment of Active Non-radiographic Axial Spondyloarthritis (SELECT-AXIS 2): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Lancet 2022 doi: 10.1016/S0140-6736(22)01212-0

Upadacitinib significantly improved the signs and symptoms of nr-axSpA compared with placebo at Week 14 in this investigation. Prior to this, upadacitinib had been shown to be effective in patients with AS. This study aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.

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Efficacy and Safety of Secukinumab in Patients with Spondyloarthritis and Enthesitis at the Achilles Tendon: Results From a Phase 3b Trial

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keab784

Secukinumab improves the burden of heel enthesitis as assessed by patient and physician reported outcomes in patients with active SpA refractory to standard treatment. In coming to this conclusion, the ACHILLES trial aimed to demonstrate the efficacy of secukinumab on Achilles’ tendon enthesitis in SpA patients.

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Efficacy and Safety of Upadacitinib for Active Ankylosing Spondylitis Refractory to Biological Therapy: A Double-blind, Randomised, Placebo-controlled Phase 3 Trial

Ann Rheum Dis 2022 doi:10.1136/annrheumdis-2022-222608

Van der Heijde et al., carried out a study to show whether upadacitinib offers an effective treatment option for bDMARD-naïve and bDMARD-IR patients with active AS. Their results indicated that upadacitinib 15 mg significantly improved the signs and symptoms of active AS. The treatment was well tolerated for 14 weeks in bDMARD-IR patients, consistent with results observed in the upadacitinib AS bDMARD-naïve study.

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Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac375

This analysis found that patients with active PsA who receive treatment with guselkumab can achieve robust and sustained low disease activity or remission. In reaching this conclusion investigators sought to evaluate the efficacy of guselkumab for the treatment of active PsA through the use of composite indices.

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Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications

Rheumatol Ther 2022 Jun;9(3):935-955. Doi: 10.1007/s40744-022-00434-z

Merola et al., reported the effect of interleukin (IL)-17A inhibition with secukinumab on cardiovascular (CV) risk parameters in patients with psoriasis, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) over 1 year of treatment. This study evaluated data from 19 secukinumab related clinical trials in phase 3/4 in psoriasis, PsA, and axSpA.

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Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial

Arthritis Res Ther. 2022 doi: 10.1186/s13075-022-02797-8

Enthesitis is a hallmark feature of SpA, including PsA and axSpA, and is proposed as the primary lesion in spondyloarthropathies. This study aimed to investigate the imaging characteristics of heel enthesitis in SpA in a post hoc analysis using the HEMRIS in blinded and centrally read MRI data from the ACHILLES trial..

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