Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis
An erratum to this article was published (RMD Open, 21 Nov 2024 ↗)
Authors' conclusion
This integrated analysis revealed no new safety concerns, and the efficacy was maintained in patients with RA under long-term ozoralizumab administration.
Study context
- Population
- Patients with rheumatoid arthritis (RA) from the OHZORA, NATSUZORA and HOSHIZORA trials401 entered extension
- Participants
- 521 patients
- Outcome
- Long-term safety (incidence rate per 100 person-year (PY) of AEs and AEs of special interest) and efficacy (disease activity index response rates, functional remission)
Methodological detailslong-term extension
- Long-term extension
Main finding
As reported in the abstract
Long-term safety and efficacy · mean treatment duration 200 weeks
Total exposure in all enrolled patients
1419.34 PY
Further findings
ACR20, ACR50 and ACR70 response rates during long-term ozoralizumab administration
- ACR20, ACR50 and ACR70 response rates maintained during the trials
Deaths
- Deaths
- 1
Safety
≥1 AE
- Patients with ≥1 AE, mostly mild to moderate
- 96.9%
- Safety analysis set
Adverse events (AEs) and AEs of special interests (AESIs) with long-term administration
- No conspicuous AEs emerged and no specific concerns in AESIs found
Original publication
Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. Published 22 August 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →