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Showing 123 results for “Phase 3”.

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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Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials

doi: 10.1007/s40744-022-00445-w

Eder, et al. sought to investigate the sex-based differences in treatment response between male and female PsA patients. They found that overall male patients had higher clinical response rates and greater improvements in the individual components of these measures.

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Two Phase 3 Trials of Baricitinib for Alopecia Areata

N Engl J Med. 2022. Epub ahead of print doi: 10.1056/NEJMoa2110343

Phase 3 trials in patients with severe alopecia areata show that baricitinib is superior to placebo with respect to hair regrowth at 36 weeks.
Alopecia areata is characterised by nonscarring hair loss that can affect any hair-bearing site. Although mild cases of this emotionally- and psychosocially-distressing autoimmune disease may resolve within 12 months, more severe forms of the disease are unlikely to remit without treatment.

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The Impact of Tofacitinib on Fatigue, Sleep, and Health‑Related Quality of Life in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Data from Phase 3 Trials

Arthritis Res Ther. 2022;24(1):83 doi:10.1186/s13075-022-02724-x

This was an exploratory post hoc analysis of pooled data, from over 2000 patients in three Phase 3 studies of tofacitinib, which demonstrates an association between tofacitinib treatment and significantly greater improvements in fatigue, sleep, and health-related quality of life (HRQoL), compared with placebo.

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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 doi: 10.1007/s40744-022-00434-z

Merola and colleagues demonstrated a rapid and sustained reduction in hsCRP and the neutrophil-lymphocyte ratio (NLR) in patients with IMIDs with a high systemic inflammatory burden treated with secukinumab.

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Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z

Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA

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The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial

Lancet. 2022. Epub ahead of print

Predefined analysis of FUTURE 5, the largest Phase 3 randomised trial of secukinumab in patients with PsA to date, demonstrates that secukinumab results in early, statistically significant, clinically meaningful, sustained improvements in PROs across all doses, compared with placebo.The fully human anti-interleukin 17A monoclonal antibody, secukinumab has shown clinical and radiographical efficacy in patients with PsA, yet the clinical significance of improvements across a wide variety of PROs r...

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