Abstract
Background/Objectives: Ozoralizumab, a tumor necrosis factor (TNF) blocker, was launched in Japan in 2022. However, there is no evidence to determine whether this biological agent is the best choice for patients with rheumatoid arthritis (RA). To investigate the clinical factors related to the efficacy of ozoralizumab, we analyzed 100 patients treated with ozoralizumab in real-world practice. Methods: 100 patients with RA treated with ozoralizumab (female, n = 87; male, n = 13), with a mean age of 61.8 years, and a mean disease duration of 10.7 years. Methotrexate (MTX) and prednisolone (PSL) were used by 49% and 10% of patients, respectively. The cohort included biologic-naïve patients (n = 39) and patients who switched from another biologic agent (n = 61). Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) positivity rates were 91% and 74%, respectively. We analyzed clinical factors associated with Disease Activity Score 28 C-reactive protein (DAS28-CRP) at 24 weeks and assessed remission, treatment continuation, and adverse-event rates. Results: DAS28-CRP decreased from 4.38 at baseline to 2.59 at 24 weeks. The remission rate was 59% at 24 weeks. DAS28-CRP at 24 weeks correlated with the anti-CCP titer in the MTX-positive group. Disease duration was correlated with DAS28-CRP at 24 weeks in the MTX-negative and biologic-naïve groups. Remission at 24 weeks was correlated with disease duration. Adverse events occurred in 9% of patients, and all cases improved. Conclusions: The efficacy and safety of ozoralizumab were confirmed in 100 patients with RA. Anti-CCP and disease duration are clinical factors that may predict the efficacy of ozoralizumab in RA. Therefore, a high anti-CCP titer or early RA may indicate the efficacy of ozoralizumab in real-world RA practice.