Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis.

IF 5.1 2区医学 Q1 RHEUMATOLOGY

RMD Open Pub Date : 2024-08-22 DOI:10.1136/rmdopen-2024-004480

Yoshiya Tanaka, Yusuke Miyazaki, Masafumi Kawanishi, Hironori Yamasaki, Tsutomu Takeuchi

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引用次数: 0

Abstract

Objectives: This study aimed to evaluate the long-term safety and efficacy profiles of ozoralizumab in patients with rheumatoid arthritis (RA) from the OHZORA, NATSUZORA and HOSHIZORA trials.

Methods: This study conducted an integrated analysis of the three trials. Patients who completed the OHZORA trial with concomitant treatment of ozoralizumab and methotrexate (MTX) or the NATSUZORA trial without MTX were eligible to participate in the long-term extension HOSHIZORA trial. Safety assessment was performed in the safety analysis set, and the incidence rate per 100 person-year (PY) was calculated for a summary of adverse events (AEs) and AEs of special interests (AESIs). The efficacy was analysed in terms of disease activity index response rates and functional remission.

Results: The OHZORA and NATSUZORA trials enrolled 521 patients, of whom 401 patients entered the HOSHIZORA trial and 279 completed the long-term extension treatment with a mean treatment duration of 200 weeks and total exposure of 1419.34 PY in all enrolled patients. Of the patients, 96.9% demonstrated ≥1 AEs, which is mostly mild to moderate. One death was observed, but no conspicuous AEs emerged and no specific concerns in AESIs were found through the long-term administration. The efficacy assessment revealed the maintained American College of Rheumatology response rates of 20%, 50%, and 70% during the trials.

Conclusion: This integrated analysis revealed no new safety concerns, and the efficacy was maintained in patients with RA under long-term ozoralizumab administration.

Trial registration number: jRCT2080223971, jRCT2080223973, NCT04077567.

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类风湿性关节炎患者使用抗肿瘤坏死因子多价 VHH 抗体 ozoralizumab 的长期安全性和疗效。

研究目的本研究旨在评估OHZORA、NATSUZORA和HOSHIZORA试验中奥唑雷珠单抗对类风湿性关节炎（RA）患者的长期安全性和疗效：本研究对三项试验进行了综合分析。完成OHZORA试验并同时接受奥佐来珠单抗和甲氨蝶呤（MTX）治疗或完成NATSUZORA试验但未接受MTX治疗的患者有资格参加长期延长的HOSHIZORA试验。安全性评估在安全性分析集中进行，并计算了不良事件（AEs）和特异性不良事件（AESIs）的每百人年（PY）发生率。疗效根据疾病活动指数应答率和功能缓解率进行分析：OHZORA和NATSUZORA试验共招募了521名患者，其中401名患者参加了HOSHIZORA试验，279名患者完成了长期延长治疗，平均疗程为200周，所有入组患者的总暴露量为1419.34PY。96.9%的患者发生了≥1例AEs，大部分为轻度至中度。观察到1例死亡，但长期用药未出现明显的不良反应，也未发现AESI方面的特殊问题。疗效评估显示，试验期间美国风湿病学会的反应率分别保持在 20%、50% 和 70%：该综合分析未发现新的安全性问题，长期服用奥佐来珠单抗的RA患者的疗效得以维持。试验注册号：jRCT2080223971、jRCT2080223973、NCT04077567。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

RMD Open RHEUMATOLOGY-

CiteScore

7.30

自引率

6.50%

发文量

205

审稿时长

14 weeks

期刊介绍： RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.