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 doi:10.1007/s40264-023-01361-w. Epub ahead of print
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 doi 10.1136/ard-2023-224803 Epub ahead of print
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 Sep 29 doi 10.1002/acr2.11601 Epub ahead of print
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.
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.
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.
Long-Term Safety and Efficacy of Ixekizumab in Patients with Axial Spondyloarthritis: 3-year Data from the COAST Program
J Rheumatol. 2023;50(8):1020–1028 doi: 10.3899/jrheum.221022
Three-year data from the ixekizumab (IXE) COAST programme provide additional evidence that patients with axSpA receiving IXE experience long-term safety, and sustained improvements in efficacy outcomes, at 3 years.
Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study
Rheumatol Ther. 2023 doi 10.1007/s40744-023-00556-y Epub ahead of print
Administration of IV-golimumab 2 mg/kg improves fatigue symptoms in axial spondylitis in a 52 Week study. At Week 16 of treatment, improvements in ASAS, ASDAS, BASDAI and SF-36 scores were observed at week 16 of treatment.
Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis
Rheumatol Ther 2023; 10:679–91 doi 10.1007/s40744-023-00536-2
Upadacitinib significantly improved patient-reported outcomes in AxSpA patients with bDMARD-IR after 14 Weeks of treatment. There were notable improvements in disease activity, pain, fatigue, function, HRQoL, and work productivity.
Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies
ACR Open Rheumatol. 2023 doi 10.1002/acr2.11537 Epub ahead of print
Post hoc analysis of guselkumab, Phase 3 DISCOVER-1 and -2 studies finds that 75% of guselkumab-randomised patients have complete resolution of dactylitis through one year.
Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients with Active Psoriatic Arthritis with and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo-Controlled DISCOVER-1 Study
ACR Open Rheumatol. 2023 doi: 10.1002/acr2.11523
TNF inhibitors (TNFi) are one main mode of therapy in patients with PsA who fail to respond to csDMARDs. However, they have a primary treatment failure rate of 40% and only a modest target of ≥20% ACR20 response. The objective of this study was to evaluate efficacy and safety of guselkumab, interleukin-23 inhibitor in the DISCOVER-1 study with active PsA patients by prior use of TNFi.