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.
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.
Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis
Rheumatol Ther. 2023;10(5):1255–1276 doi: 10.1007/s40744-023-00576-8
The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.
Rheumatol Ther. 2023;10(4):849-860 doi: 10.1007/s40744-023-00548-y
Secukinumab reduced disease activity across a range of outcome measures by week 12, with sustained responses through 52 weeks.
Secukinumab Improves Physical Function and Quality of Life and Inhibits Structural Damage in Patients with PsA with Sustained Remission or Low Disease Activity: Results From the 2-year Phase 3 FUTURE 5 Study
RMD Open 2023;9:e002939 doi 10.1136/rmdopen-2022-002939
Results from the 2-year phase 3 study FUTURE 5 show that the majority of patients with PsA who are treated with secukinumab were able to achieve sustained low disease activity or remission by week 104.
Efficacy and Safety of Upadacitinib in Patients with Active Psoriatic Arthritis and Axial Involvement: Results From Two Phase 3 Studies
Arthritis Res Ther. 2023;25(1):56 doi 10.1186/s13075-023-03027-5
Evidence from two phase 3 RCTs showed that patients with PsA and axial involvement had greater responses when treated with a once-daily oral dose of 15 mg upadacitinib versus placebo, and a similar or greater response versus adalimumab. Safety results were comparable between patients with or without axial involvement.
The Effect of Guselkumab on Inhibiting Radiographic Progression in Patients with Active Psoriatic Arthritis: Study Protocol for APEX, a Phase 3b, Multicenter, Randomized, Double‑blind, Placebo‑controlled Trial
Trials. 2023 doi: 10.1186/s13063-022-06945-y
Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.
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.
Bimekizumab In Patients with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumour Necrosis Factor-Α Inhibitors: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial
Lancet. 2023 doi: 10.1016/S0140-6736(22)02303-0
This study showed rapid and clinically meaningful improvements with bimekizumab treatment in patients experiencing active PsA and showing an inadequate response or intolerance to TNFα inhibitors. Its chief aim was to evaluate the efficacy and safety of bimekizumab in patients with an inadequate response or intolerance to TNFα inhibitors.