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 doi: 10.1136/ard-2023-224431. Epub ahead of print
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.
Guselkumab Modulates Differentially Expressed Genes in Blood of Patients with Psoriatic Arthritis: Results from Two Phase 3, Randomized, Placebo-Controlled Trials
ACR Open Rheumatol. 2023 doi: 10.1002/acr2.11589
Whole blood transcriptome profiling reveals differential gene expression in patients with active PsA from the DISCOVER-1 and DISCOVER-2 clinical studies in comparison with healthy controls.
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.
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.
Bimekizumab in Patients with Psoriatic Arthritis, Naive To Biologic Treatment: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial (BE OPTIMAL)
Lancet. 2023 doi: 10.1016/S0140-6736(22)02302-9
This study showed that bimekizumab treatment resulted in clinically meaningful and consistent improvements across multiple measures in bDMARD-naïve patients with active PsA. It aimed to assess the efficacy and safety of bimekizumab in patients with active PsA who were naive to bDMARDs.
Safety and Efficacy of Bimekizumab in Patients with Active Psoriatic Arthritis: 3-Year Results from a Phase 2b Randomized Controlled Trial and its Open-Label Extension Study
Arthritis Rheumatol 2022 doi: 10.1002/art.42280
In this investigation bimekizumab was associated with a sustained ACR50 improvement. This was highlighted following the attempt to describe the long-term safety, tolerability, and efficacy of up to three years of bimekizumab treatment in PsA patients
Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis
Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac375
This analysis found that patients with active PsA who receive treatment with guselkumab can achieve robust and sustained low disease activity or remission. In reaching this conclusion investigators sought to evaluate the efficacy of guselkumab for the treatment of active PsA through the use of composite indices.