Spondyloarthritis & psoriatic arthritis
Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies
Authors' conclusion
The safety profile of bimekizumab remained consistent with prior reports, with no new safety signals identified. 1-year efficacy was sustained to 2 years across patients with nr-axSpA and r-axSpA.
Study context
- Population
- Patients with nr-axSpA (BE MOBILE 1) and r-axSpA (BE MOBILE 2) completing week 52randomised
- Participants
- 586 patients
Methodological detailsBE MOBILE 1 and 2, ongoing
- BE MOBILE 1 and 2
- Ongoing
Primary result
As reported in the abstract
ASAS40 response, ASDAS low disease activity (<2.1) and ASDAS inactive disease (<1.3) in randomised patients · week 104
ASAS40 response
>50%
Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (<2.1)
∼60%
ASDAS inactive disease (<1.3)
>30%
MRI remission
>57%
Further findings
MACE and deaths · weeks 52 - 104
- No MACE or deaths occurred
- Inflammatory bowel disease and uveitis rates were low
- No MACE or deaths occurred
- Inflammatory bowel disease and uveitis rates were low
Safety
≥1 treatment-emergent adverse event (TEAE) in the open-label extension (OLE) (weeks 52 - 104)
- Patients with ≥1 TEAE
- 70.8% (367/518)
Most frequent TEAEs (EAIR/100PY) · weeks 52 - 104
- SARS-CoV-2 (COVID-19) infection
- 25.2
- Nasopharyngitis
- 11.0
- Oral candidiasis
- 5.4
Fungal infection (EAIR/100PY) · weeks 52 - 104
- Fungal infection
- 11.8
- Candida infections
- 6.8
- Most mild/moderate, none serious/systemic
Original publication
Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies. Rheumatology (Oxford). Published 11 January 2025. doi:10.
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