Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment
An erratum to this article was published (Ann Rheum Dis, Feb 2025 ↗)
Authors' conclusion
The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106.
Study context
- Population
- Subjects with active rheumatoid arthritis (RA)
- Participants
- 2,304 subjects
- Comparison
- Olokizumab (OKZ) every 2 weeks vs OKZ every 4 weeks, each with methotrexate (MTX)
- Outcome
- Long-term safety and tolerability (treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest, laboratory results)
- Follow-up
- 106 weeks
Methodological detailspooled data
- Pooled data
Pooled result
As reported in the abstract
SAEs, event rate per 100 patient-years
Further pooled results
- Clinical response rates remained stable during the open-label extension (OLE)
Safety
Serious infections, event rate per 100 patient-years
Gastrointestinal perforations, event rate per 100 patient-years
MACE, event rate per 100 patient-years
Malignancies, event rate per 100 patient-years
Laboratory variables
- Expected changes, like neutropenia, elevation of liver enzymes and blood lipids
Original publication
Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment. Ann Rheum Dis. Published 21 October 2024. doi:10. 1136/ ard-2023-225473
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