Rheumatoid arthritis

Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment

Ann Rheum DisPublished Pooled analysis of three phase 3 randomised controlled trials and their open-label extension

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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