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Showing 69 results for “Phase II”.

Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets with Apremilast: Phase III Results in DMARD-naïve Patients With Psoriatic Arthritis

J Rheumatol. 2022 doi: 10.3899/jrheum.210906

Baseline disease activity, as measured by cDAPSA, predicts the achievement of treatment targets in DMARD-naïve patients post- apremilast treatment. To come to this conclusion Mease, et al.  analysed data from the PALACE 4 clinical trial which investigated apremilast in DMARD-naïve patients. 175 patients receiving 30mg apremilast from baseline with cDAPSA data available, were analysed.

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Efficacy and Safety of Selective TYK2 Inhibitor, Deucravacitinib, in a Phase II Trial in Psoriatic Arthritis

Ann Rheum Dis. 2022 doi: 10.1136/annrheumdis-2021-221664

In this study Mease, et al. aimed to evaluate the efficacy and safety of deucravacitinib in patients with active PsA. Treatment with the selective TYK2i deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20 as well as Multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients.

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Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials

Advance Therapy,2022 Jun;39(6):2806-2819. doi.org/10.1007/s12325−022−02132−2

van der Horst-Bruinsma et al., carried out a post-hoc analysis to confirm that the clinical presentations and responses to ixekizumab therapy may differ in male and female patients.

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Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging

Rheumatology Expert, 2022 DOI: 10.1093/rheumatology/keac104

Maksymowych et al., evaluated the efficacy of Ixekizumab in patients with radiographic axial spondyloarthritis (r-axSpA) with and without objective measures of inflammation.

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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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Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE

doi: 10.1093/rheumatology/keab628

D'Agostino, et al. aimed to evaluate whether treatment with secukinumab inhibits synovitis in patients with active PsA, as measured by PDUS. They found that secukinumab rapidly and significantly decreased synovitis, indicating a direct effect of IL-17 inhibition on the synovium in patients with PsA.

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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 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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Pain Reduction in Rheumatoid Arthritis Patients Who Use Opioids: A Post Hoc Analysis of Phase 3 Trials of Baricitinib

ACR Open Rheumatol. 2021. Epub ahead of print. doi: 10.1002/acr2.11380

This post hoc analysis shows that pain reduction was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg, but not adalimumab.Use of opioids to treat RA-related pain has increased, yet long-term use has been associated with reduced efficacy and safety concerns. In addition, the misuse of opioids has resulted in a public health crisis in the United States and highlights the need for safe, effective nonaddictive alternatives for pain management. As such, Pope, et al. assessed p...

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