Spondyloarthritis & psoriatic arthritis
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
Authors' conclusion
Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.
Study context
- Population
- Patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to TNFi who completed the 16-week BE COMPLETE study347 completed week 52
- Participants
- 400 patients
- Comparison
- Bimekizumab 160 mg every 4 weeks; bimekizumab-randomised vs placebo/bimekizumab (switched at week 16)
- Primary endpoint
- Safety (TEAEs, exposure-adjusted incidence rate/100 patient-years) and efficacy
- Follow-up
- Week 52
Methodological detailsopen-label extension (BE VITAL), parent study double-blind, placebo-controlled, 52-week safety and efficacy, Most frequent treatment-emergent adverse event (TEAEs): SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis, urinary tract infection
- Open-label extension (BE VITAL)
- Parent study double-blind, placebo-controlled
- 52-week safety and efficacy
- Most frequent TEAEs: SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis, urinary tract infection
Primary result
As reported in the abstract
TEAEs, exposure-adjusted incidence rate/100 patient-years
≥1 TEAE, EAIR/100 patient-years
126.0
Serious TEAEs, EAIR/100 patient-years
7.0
Further findings
ACR50 · week 52
Complete skin clearance (PASI 100) · week 52
MDA · week 52
Clinical and patient-reported outcomes · week 16 to 52
- Sustained efficacy with bimekizumab from week 16 to 52
Sudden death
- Sudden deaths
- 1
Safety
Discontinuation due to oral candidiasis · week 52
- Patients discontinued due to oral candidiasis
- 2
- All fungal infections mild or moderate and localised
Active tuberculosis, uveitis or inflammatory bowel disease
- No cases reported
Original publication
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. RMD Open. Published 22 February 2024. doi:10.
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