Trial reportRMD open2024
Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL.
Trial report in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Pooled it
- Risk of new-onset inflammatory bowel disease in psoriasis patients treated with five different interleukin inhibitors: a systematic review and meta-analysis.Frontiers in immunology · 2025Pooled it
- Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week-24 Results of a Phase 3, Randomized, Placebo-Controlled Study.Arthritis & rheumatology (Hoboken, N.J.) · 2026Trial
- Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies.Rheumatology (Oxford, England) · 2026Trial
- Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies.Rheumatology (Oxford, England) · 2024Trial
- Antibody-Based Therapeutics in Autoimmune Diseases: Mechanisms, Challenges, and Future Perspectives.International journal of molecular sciences · 2026Review
- A narrative review on radiographic progression to monitor psoriatic arthritis activity.Advances in rheumatology (London, England) · 2026Review
- Does Prior Exposure Affect Retention? A Real-World, Multicentre Assessment of IL-17 Inhibitor Cycling in Psoriatic Arthritis.Rheumatology and therapy · 2026Article
- Exploring biomarkers for treatment response in psoriatic arthritis: a focus on multi-omics technologies.The pharmacogenomics journal · 2026Review
- Control of Inflammation and Sustained Improvements in Patient-Reported Outcomes in Patients With Psoriatic Arthritis: Bimekizumab Two-Year Results From Two Phase 3 Studies.ACR open rheumatology · 2026Article
- Observational
- Emerging Targets in Psoriatic Arthritis: Dual IL-17A/F and Selective TYK2 Inhibition in a Clinical Perspective.Mediterranean journal of rheumatology · 2026Review
- The Pathophysiological Significance of Dual Inhibition of IL-17A and IL-17F in Psoriatic Arthritis and Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2026Review
- Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year.Dermatology and therapy · 2026Article
- Sustained improvements in health status and work productivity with bimekizumab in psoriatic arthritis: 2-year results from two phase 3 studies.Rheumatology advances in practice · 2026Article
- Effectiveness of Bimekizumab in Psoriatic Arthritis: A Multicenter Real-Life Study With Clinical and Ultrasound Evaluation in the Lazio Region, Italy.International journal of dermatology · 2025Observational
- Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector.Dermatology and therapy · 2025Article
- Bimekizumab in the Treatment of Axial Spondyloarthritis and Psoriatic Arthritis: A New Kid on the Block.International journal of molecular sciences · 2025Review
- IL-23 blockade in a patient with psoriasis andSAGE open medical case reports · 2025Article
- Management of tuberculosis risk, screening and preventive therapy in patients with chronic autoimmune arthritis undergoing biotechnological and targeted immunosuppressive agents.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 15 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors.
methodsPatients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52.
resultsA total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to 52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52.
conclusionsBimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.