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.
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.
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.
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.
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.
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.
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.
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.
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.
Anti-GM-CSF Otilimab Versus Tofacitinib or Placebo in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Conventional or Biologic DMARDs: Two Phase 3 Randomised Trials (contRAst 1 and contRAst 2)
Ann Rheum Dis 2023;0:1–11 doi 10.1136/ard-2023-224482
Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.