Spondyloarthritis & psoriatic arthritis
Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension
Authors' conclusion
The safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48.
Study context
- Population
- Patients with active radiographic axial spondyloarthritis (r-axSpA) completing the dose-ranging 48-week RCT202 completed Week 256
- Participants
- 303 patients
- Primary endpoint
- Long-term safety, tolerability and efficacy
- Follow-up
- 256 weeks
Methodological detailsBE AGILE, dose-ranging 48-week RCT
- BE AGILE
- Dose-ranging 48-week RCT
Primary result
As reported in the abstract
Patients with ≥1 treatment-emergent adverse event (TEAE)
289 of 303
95.4%
Further findings
ASAS40 response · Week 256
- ASAS40 response, non-responder imputation (NRI)
- 49.7%
- ASAS40 response, observed case (OC)
- 73.1%
Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity · Week 256
- ASDAS low disease activity, NRI
- 41.6%
- ASDAS low disease activity, OC
- 71.1%
Mean ASDAS (SE; Multiple Imputation (MI)) · Baseline, Week 48, Week 256
- Mean ASDAS at baseline (SE 0.1)
- 3.9
- Mean ASDAS at Week 48 (SE 0.1)
- 2.1
- Improvement maintained to Week 256
Pain, fatigue, physical function and health-related quality of life · Week 256
- Improvements sustained
Safety
Nasopharyngitis · Weeks 0-256
- Nasopharyngitis
- 21.8%
Upper respiratory tract infection · Weeks 0-256
- Upper respiratory tract infection
- 14.5%
Fungal infections (EAIR/100 patient-years) · Weeks 0-256
- Fungal infections EAIR
- 7.4
- Candida infections EAIR
- 2.6
- Oral candidiasis EAIR
- 2.2
- Systemic fungal infections
- 0
Serious infections and active tuberculosis · Weeks 0-256
- Serious infections EAIR
- 1.4
- Active tuberculosis
- 0
Active inflammatory bowel disease and anterior uveitis (EAIR) · Weeks 0-256
- Active inflammatory bowel disease EAIR
- 0.8
- Anterior uveitis EAIR
- 0.7
Discontinuation due to TEAEs · Weeks 0-256
- Discontinued treatment due to TEAEs
- 42 (13.9%)
Original publication
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