Efficacy and pharmacokinetics of ozoralizumab, an anti-TNFα NANOBODY® compound, in patients with rheumatoid arthritis: 52-week results from the OHZORA and NATSUZORA trials
Authors' conclusion
OZR showed a long half-life and favorable PK properties. A post hoc analysis suggested sustained efficacy independent of trough concentration by subcutaneous administration of OZR 30 mg at 4-week intervals for 52 weeks.
Study context
- Population
- Japanese patients with rheumatoid arthritis (RA); OHZORA with methotrexate (MTX), NATSUZORA without concomitant MTXOHZORA n = 381 · OHZORA with MTX 381 · NATSUZORA without concomitant MTX 140
- Comparison
- Ozoralizumab 30 mg vs 80 mg every 4 weeks, with MTX or without MTX
- Primary endpoint
- Pharmacokinetics (PK) of OZR and its correlation with clinical efficacy
Methodological detailspost hoc analysis, pharmacokinetic analysis, 52 weeks
- Post hoc analysis
- Pharmacokinetic analysis
- 52 weeks
Primary result
As reported in the abstract
PK of OZR
Time to Cmax, 30 and 80 mg
6 days
Elimination half-life
18 days
Further findings
Trough concentration cutoff for ACR20/ACR50 (ROC, post hoc) · week 16
- Cutoff trough concentration approximately, both trials
- 1 μg/mL
- Efficacy higher with trough ≥ 1 μg/mL than < 1 μg/mL at week 16; no clear cutoff at week 52
- Retrospectively performed
Original publication
Efficacy and pharmacokinetics of ozoralizumab, an anti-TNFα NANOBODY® compound, in patients with rheumatoid arthritis: 52-week results from the OHZORA and NATSUZORA trials. Arthritis Res Ther. Published 13 April 2023. doi:10.
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