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Showing 186 results for “Phase 3”.

February 2024

Validity and Score Interpretation of the 12-item Psoriatic Arthritis Impact of Disease: An Analysis of Pooled Data from Two Phase 3 Trials of Bimekizumab in Patients with Psoriatic Arthritis

RMD Open 2024;10(1):e003548 doi: 10.1136/rmdopen-2023-003548

This study reports that the PsAID-12 total score and individual PsAID items capturing disease concepts important to patients with PsA demonstrated robust psychometric properties.

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January 2024

Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis)

Rheumatol Ther 2023;11(1):177–189 doi 10.1007/s40744-023-00619-0

This post hoc analysis by Curtis, et al. found that current and former smokers were more likely to switch from an anti-TNF bDMARD to a different bDMARD or JAK inhibitor in comparison to non-smokers. They also found that DAS28(CRP) ≤3.2 achievement was significantly higher after filgotinib therapy regardless of smoking status in MTX-IR, bDMARD-IR, and MTX-naïve patients.

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Effects of Secukinumab on Synovitis and Enthesitis in Patients with Psoriatic Arthritis: 52-week Clinical and Ultrasound Results from the Randomised, Double-blind ULTIMATE Trial with Open Label Extension

Semin Arthritis Rheum 2023;63:152259

This Phase 3 RCT by D’Agostino, et al. assessed the long-term effect of secukinumab to placebo at tissue level on synovitis and enthesitis, and across all PsA manifestations. They found consistent improvements in clinically and ultrasound-assessed synovitis and enthesitis.

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December 2023

Patient Clusters Identified by Machine Learning from a Pooled Analysis of the Clinical Development Programme of Secukinumab in Psoriatic Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis with Axial Manifestations

Clin Exp Rheumatol. 2023 doi: 10.55563/clinexprheumatol/b8co74 Epub ahead of print

Psoriatic arthritis clusters, obtained by machine learning (ML) analysis of pooled data from the FUTURE, MEASURE, and MAXIMISE trials, indicate phenotypical heterogeneity of patients with PsA and axial manifestations and overlapping features across the spondyloarthritis spectrum. Here, Baraliakos, et al. sort to identify distinct clinical clusters, based on patient demographics and baseline clinical indicators, from the secukinumab clinical development programme.

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MACE and VTE across Upadacitinib Clinical Trial Programmes in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

RMD Open 2023; 9(4):e003392 doi 10.1136/rmdopen-2023-003392

Rates of MACE and VTE events in patients with RA or PsA treated are consistent across 15 mg and 30 mg doses of upadacitinib, and comparable with active comparators adalimumab and MTX. Several risk factors were also identified for MACE and VTE events in patients with RA.

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Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis

Rheumatol Ther 2023;11(1):97–112 doi 10.1007/s40744-023-00621-6

Rates of malignancy were similar between upadacitinib, adalimumab, and MTX. They were also consistent across RA, PsA, AS and nr-axSpA. A dose-dependent increased rate of NMSC was observed with upadacitinib in RA. For RA and PsA, being older (≥65 years) and male was associated with
an increased risk of malignancy excluding NMSC.

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November 2023

Tofacitinib Efficacy and Safety in Patients With Ankylosing Spondylitis by Prior Biologic Disease-Modifying Antirheumatic Drug Use: A Post Hoc Analysis

ACR Open Rheumatol. 2023;5(12)632–643 doi 10.1002/acr2.11601

In this post hoc analysis by Deoodhar, et al., the authors found that tofacitinib demonstrated greater efficacy than placebo in bDMARD-naïve and TNFi-IR AS patients. They also found that safety event rates for tofacitinib therapy were numerically higher in the TNFi-IR subgroup than the bDMARD-naïve subgroup.

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Bimekizumab Treatment in Patients With Active Axial Spondyloarthritis: 52-week Efficacy and Safety from the Randomised Parallel Phase 3 BE MOBILE 1 and BE MOBILE 2 Studies

Ann Rheum Dis. 2023;83(2):199–213 doi 10.1136/ard-2023-224803

Baraliakos, et al. present data from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, that investigated the clinical efficacy and safety of bimekizumab in axSpA patients. They found that bimekizumab had sustained and consistent efficacy in patients with nr-axSpA and r-axSpA.

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Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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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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