RMD open · 2025
Early effects of ozoralizumab 30 mg in patients with rheumatoid arthritis and inadequate response to methotrexate: a post hoc trajectory analysis of the phase II/III OHZORA trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Miyazaki Yusuke, Horiuchi Nobuko, Okamoto Shunsuke, Matsumoto Rumiko, Takeuchi Tsutomu, Tanaka Yoshiya
Аннотация
OBJECTIVE: This study assessed the early effects of ozoralizumab (OZR) 30 mg in patients with rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX-IR), drawing on OHZORA trial data for efficacy and safety insights.
METHODS: The study included 141 patients with RA from the OHZORA trial, initiated on OZR 30 mg. The primary measure was the rate of achieving low disease activity (LDA) by the Clinical Disease Activity Index (CDAI) 3 days post-OZR initiation. Growth mixture modelling (GMM) of CDAI trajectories was performed to enable a more detailed analysis of the impact of OZR on disease activity improvement.
RESULTS: The retention rate of OZR up to 52 weeks was 87.9% (n=124). The LDA achievement rate on the third day of OZR introduction was 12.8% (n=18), and by week 52, 70.9% (n=100) had improved to LDA. Three distinct groups were identified using GMM: one group (n=78) reached LDA within 4 weeks of OZR initiation and maintained LDA up to week 52. Multiple logistic regression analysis revealed that both low baseline C-reactive protein (CRP) and low CDAI were independently associated with group membership.
CONCLUSION: OZR 30 mg demonstrated both immediate and sustained efficacy in MTX-IR patients with RA. Multivariate analysis suggested that both baseline inflammation and disease activity-represented by CRP and CDAI-may independently influence treatment response. However, residual confounding due to baseline disease activity cannot be completely excluded, and this remains a limitation of the present study.
METHODS: The study included 141 patients with RA from the OHZORA trial, initiated on OZR 30 mg. The primary measure was the rate of achieving low disease activity (LDA) by the Clinical Disease Activity Index (CDAI) 3 days post-OZR initiation. Growth mixture modelling (GMM) of CDAI trajectories was performed to enable a more detailed analysis of the impact of OZR on disease activity improvement.
RESULTS: The retention rate of OZR up to 52 weeks was 87.9% (n=124). The LDA achievement rate on the third day of OZR introduction was 12.8% (n=18), and by week 52, 70.9% (n=100) had improved to LDA. Three distinct groups were identified using GMM: one group (n=78) reached LDA within 4 weeks of OZR initiation and maintained LDA up to week 52. Multiple logistic regression analysis revealed that both low baseline C-reactive protein (CRP) and low CDAI were independently associated with group membership.
CONCLUSION: OZR 30 mg demonstrated both immediate and sustained efficacy in MTX-IR patients with RA. Multivariate analysis suggested that both baseline inflammation and disease activity-represented by CRP and CDAI-may independently influence treatment response. However, residual confounding due to baseline disease activity cannot be completely excluded, and this remains a limitation of the present study.