Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment.

IF 20.3 1区 医学 Q1 RHEUMATOLOGY Annals of the Rheumatic Diseases Pub Date : 2024-10-21 DOI:10.1136/ard-2023-225473
Eugen Feist, Roy M Fleischmann, Saeed Fatenejad, Daria Bukhanova, Sergey Grishin, Sofia Kuzkina, Michael Luggen, Evgeniy Nasonov, Mikhail Samsonov, Josef S Smolen
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Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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奥洛单抗加甲氨蝶呤:106 周治疗的安全性和有效性。
目的利用三项随机临床试验(RCT)和开放标签扩展研究(OLE)的汇总数据,报告奥洛珠单抗(OKZ)联合甲氨蝶呤(MTX)治疗活动性类风湿性关节炎(RA)患者的长期安全性和耐受性:分析了三项三期核心试验及其开放标签扩展研究的累积数据。评估的安全性变量包括治疗突发不良事件(AE)、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 反应、疾病活动评分 28(C 反应蛋白)结果:共有2304名患者接受了OKZ与MTX联合治疗,治疗方案为每2周1次或每4周1次。OKZ每2周1次和OKZ每4周1次的每100例患者年SAE发生率分别为9.57和9.13;严重感染发生率分别为2.95和2.34;胃肠道穿孔发生率分别为0.09和0.05;主要心血管不良事件发生率分别为0.58和0.83;恶性肿瘤发生率分别为0.45和0.50。在106周的治疗过程中,未观察到任何不良反应发生率的增加。实验室变量评估显示了预期的变化,如中性粒细胞减少、肝酶和血脂升高。在OLE期间,临床反应率保持稳定:OKZ联合MTX的长期安全性和耐受性保持稳定。结论:OKZ 与 MTX 联用的长期安全性和耐受性保持稳定,OKZ 的疗效维持到第 106 周。这些研究结果支持将 OKZ 作为活动性 RA 患者的一种治疗选择。
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来源期刊
Annals of the Rheumatic Diseases
Annals of the Rheumatic Diseases 医学-风湿病学
CiteScore
35.00
自引率
9.90%
发文量
3728
审稿时长
1.4 months
期刊介绍: Annals of the Rheumatic Diseases (ARD) is an international peer-reviewed journal covering all aspects of rheumatology, which includes the full spectrum of musculoskeletal conditions, arthritic disease, and connective tissue disorders. ARD publishes basic, clinical, and translational scientific research, including the most important recommendations for the management of various conditions.
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