Rheumatology and Clinical Immunology, HELIOS Fachklinik Vogelsang/Gommern, Vogelsang, Germany
Experimental Rheumatology, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.
Ann Rheum Dis. 2024 Oct 21;83(11):1454-1464. doi: 10.1136/ard-2023-225473.
To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study.
Cumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission.
A total of 2304 patients received OKZ in combination with MTX either once every 2 weeks or once every 4 weeks. Event rates per 100 patient-years in OKZ every 2 weeks and OKZ every 4 weeks, respectively, were 9.57 and 9.13 for SAEs; 2.95 and 2.34 for serious infections; 0.09 and 0.05 for gastrointestinal perforations; 0.58 and 0.83 for major adverse cardiovascular events; and 0.45 and 0.50 for malignancies. No increase in the rate of any AE was observed over 106 weeks of treatment. The evaluation of laboratory variables demonstrated the expected changes, like neutropenia, elevation of liver enzymes and blood lipids. Clinical response rates remained stable during the OLE.
The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA.
报告奥洛珠单抗（OKZ）联合甲氨蝶呤（MTX）治疗活动期类风湿关节炎（RA）患者的长期安全性和耐受性，数据来自三项随机对照临床试验（RCT）的汇总数据和开放性扩展（OLE）研究。
分析三项 3 期核心试验及其 OLE 的累积数据。评估的安全性变量包括治疗出现的不良事件（TEAE）、严重不良事件（SAE）、特别关注的不良事件和实验室结果。疗效评估包括 ACR20/50/70 缓解率、DAS28（CRP）<3.2、CDAI 缓解且低疾病活动度（LDA）、SDAI 缓解且 LDA、HAQ-DI 下降 0.22 单位和布尔 2.0 缓解。
共 2304 例患者接受了 OKZ 联合 MTX 治疗，给药方案分别为每 2 周 1 次或每 4 周 1 次。OKZ 每 2 周和每 4 周治疗的患者每 100 人年的事件发生率分别为 SAE：9.57 和 9.13；严重感染：2.95 和 2.34；胃肠道穿孔：0.09 和 0.05；主要不良心血管事件：0.58 和 0.83；恶性肿瘤：0.45 和 0.50。治疗 106 周内未观察到任何 AE 发生率增加。实验室变量的评估显示出预期的变化，如中性粒细胞减少、肝酶和血脂升高。OLE 期间临床缓解率保持稳定。
OKZ 联合 MTX 的长期安全性和耐受性保持稳定。OKZ 的疗效在第 106 周时保持稳定。这些发现支持 OKZ 作为治疗活动期 RA 患者的一种选择。
