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.
Sex-related Differences in Patient Characteristics, and Efficacy and Safety of Advanced Therapies in Randomised Clinical Trials in Psoriatic Arthritis: A Systematic Literature Review and Meta-analysis
Lancet Rheumatol 2023;5:e716–27
In this study, Eder, et al. performed a systematic literature review and meta-analysis of RCTs to assess information on participants’ characteristics and rates of American College of Rheumatology response and minimal disease activity by sex. The authors found that the biological sex of patients with PsA influences their response to advanced therapies, but the effect varies by drug class.
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.
Gender-specific Differences in Patients with Psoriatic Arthritis Receiving Ustekinumab or Tumour Necrosis Factor Inhibitor: Real-world Data
Rheumatology (Oxford) doi:10.1093/rheumatology/kead089.
Real-world data from the PsABio study indicated that females with PsA had more severe disease than males before the initiation of treatment. While both genders experienced treatment related improvements, fewer females than males were able to achieve a favourable disease state within 12 months. Treatment discontinuation and switching were also higher in females than males, due to lower efficacy and adverse events.
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 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.
Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
Rheumatol Ther. 2023;10(6):1503–1508 doi: 10.1007/s40744-023-00589-3
In the UPJOINT open label study, the proportion of patients with PsA, and an inadequate response to csDMARDs or bDMARDs, who achieved minimal disease activity with upadacitinib was in line with the results of previous studies at 24 weeks. No new safety signals were identified.
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients with Active Ankylosing Spondylitis
J Clin Rheumatol. 2023;29(5):223–229 doi: 10.1097/RHU.0000000000001973
Phase 2a study assessing the efficacy and safety of tildrakizumab in patients with active AS fails to meet the primary endpoint.
Differences and Similarities Between the EULAR/ASAS-EULAR and National Recommendations for Treatment of Patients with Psoriatic Arthritis and Axial Spondyloarthritis Across Europe
Lancet Reg Health Eur. 2023;33:100706 doi: 10.1016/j.lanepe.2023.100706
Comparing the alignment of European national recommendations for patients with PsA and axSpA with EULAR and ASAS-EULAR treatment recommendations found that only a minority of national treatment recommendations were completely aligned.