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Showing 46 results for “phase III”.

October 2023

Anti-gm-csf Otilimab versus Sarilumab or Placebo in Patients with Rheumatoid Arthritis and Inadequate Response to Targeted Therapies: A Phase III Randomised Trial (contRAst 3)

Ann Rheum Dis. 2023;82(12):1527–1537 doi 10.1136/ard-2023-224449

The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

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Prevention of Radiographic Progression in Higher-Risk Patients with Rheumatoid Arthritis Using Filgotinib in Phase III Studies: Narrative Review of Post Hoc Analyses

Rheumatol Ther. 2023;10(6):1399–1415 doi: 10.1007/s40744-023-00590-w

Findings from post hoc analyses extend the knowledge base for radiographic benefits of filgotinib in patients with RA.

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Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from the Phase III, Randomised, Placebo-Controlled, Active Reference BE OPTIMAL Study

Ann Rheum Dis. 2023;82(11):1404–1414 doi: 10.1136/ard-2023-224431

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

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Efficacy and Safety of Upadacitinib in Patients with Ankylosing Spondylitis Refractory to Biologic Therapy: 1-year Results From the Open-label Extension of a Phase III Study

Arthritis Res Ther 2023; 2023;18;25(1):172 doi 10.1186/s13075-023-03128-1

The efficacy and safety of updacitinib in bDMARD-IR patients with AS were sustained through to one year in an open-label extension of the SELECT-AXIS 2 study.

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September 2023

The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2

Ther Adv Musculoskelet Dis. 2023;15:1759720X231189005 doi: 10.1177/1759720X231189005

Post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 concludes that ixekizumab (IXE) is effective in improving axial symptoms in patients with active PsA presenting with axial manifestations.

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July 2023

Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

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October 2022

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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July 2022

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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June 2022

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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