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Showing 73 results for “Phase II”.

Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study

Arthritis Rheumatol. 2022;74:1943–58

In this open-label extension study of BE AGILE, the safety profile of bimekizumab was found to be consistent with previously demonstrated findings, and no new safety signals were identified. The objective was to assess the long-term safety, tolerability, and efficacy of bimekizumab in patients with active AS.

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Safety and Efficacy of Bimekizumab in Patients With Active Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study

Arthritis Rheumatol. 2022 doi: 10.1002/art.42280

This study highlighted that the safety of bimekizumab in patients with PsA over 3 years of treatment was consistent with the previous 48-week results, as well as other recently published studies of IL-17 inhibitors in PsA patients.

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Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a Randomized Phase IIb Study of Abatacept in Psoriatic Arthritis

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac073

In this study abatacept 30/10 mg/kg and 10 mg/kg doses were associated with greater improvements from baseline in MRI detected synovitis and tenosynovitis, respectively, compared with placebo, confirming the clinical outcomes. Indeed, inflammatory components demonstrated the greatest change from baseline.

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Comparative Performance of Composite Measures From Two Phase III Clinical Trials of Ixekizumab in Psoriatic Arthritis

RMD Open. 2022 doi: 10.1136/rmdopen-2022-002457

In this latest investigation into ixekizumab more patients achieved targets assessed by mCPDAI and DAPSA than with other composites. This study assess’ the concordance and variability in performance of the composite measures in patients with PsA, as well as to provide greater granularity to the frequency and severity of residual symptoms in patients who achieve treatment targets.

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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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