Efficacy and pharmacokinetics of ozoralizumab, an anti-TNFα NANOBODY^® compound, in patients with rheumatoid arthritis: 52-week results from the OHZORA and NATSUZORA trials.

ABSTRACT:

Introduction

Ozoralizumab (OZR), a tumor necrosis factor alpha (TNFα) inhibitor, is a NANOBODY^® compound that binds to TNFα and human serum albumin. The main objective of this study was to analyze the pharmacokinetics (PK) of the drug and its correlation with clinical efficacy in patients with rheumatoid arthritis (RA).

Methods

Efficacy data were analyzed from the OHZORA trial, in which OZR 30 or 80 mg was administered to Japanese patients with RA at 4-week intervals for 52 weeks in combination with methotrexate (MTX; n = 381), and the NATSUZORA trial, in which OZR 30 or 80 mg was administered without concomitant MTX (n = 140). Effects of patient baseline characteristics and anti-drug antibodies (ADAs) on the PK and efficacy of OZR were investigated, and a post ho

SUBMITTER: Takeuchi T 

PROVIDER: S-EPMC10099673 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature