In both studies, researchers collected trough concentrations of ozoralizumab and anti-drug-antibody levels at baseline, varying times throughout the study and follow-up. The presence of neutralizing antibodies was also evaluated.
Results
The maximum plasma concentration was attained at day 6 in the patients who received 30 mg and 80 mg of ozoralizumab. Ozoralizumab exhibited an 18-day elimination half-life. Additionally, the exposure of ozoralizumab correlated negatively with patient body weight but was not affected by other variables. Overall, anti-drug antibodies had little effect on drug efficacy. In the NATSUZORA trial, neutralizing antibodies had some effect on the exposure and efficacy of ozoralizumab.
In both trials, the effect of trough concentration on the ACR20 and ACR50 response rates of patients was retrospectively examined and a cutoff trough concentration of approximately 1 μg/mL at week 16 was obtained. The efficacy indicators in the subgroup with trough concentration of ≥1 μg/mL were higher than those in the <1 μg/mL subgroup at week 16. In both trials, no clear cutoff was obtained at week 52.
Conclusion
These study results suggest 30 mg of ozoralizumab can be taken every four weeks—the recommended clinical dosage and administration frequency—due to its long half-life and good pharmacokinetic properties, which are unlikely to be influenced by patient background variables, with the exception of body weight.
These results show that ozoralizumab was more effective when the trough concentration at week 16 was greater than 1 μg/mL. The drug is also well tolerated.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- News release: Notification of application for approval to manufacture and market rheumatoid arthritis therapy Nanozora 30 mg autoinjectors for SC injection in Japan. Taisho Pharmaceutical Holdings Co. Ltd. 2022 Sep 28.
- News release: Notification of approval to manufacture and market Nanozora 30 mg autoinjectors for SC injection in Japan. Taisho Pharmaceutical Holdings Co. Ltd. 2023 Aug 1.
- Bao G, Tang M, Zhao J, et al. Nanobody: A promising toolkit for molecular imaging and disease therapy. EJNMMI Res. 2021 Jan 19;11(1):6.
- Takeuchi T, Chino Y, Kawanishi M, et al. 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. 2023 Apr 13;25(1):60.
