奥洛珠单抗治疗类风湿性关节炎的有效性和安全性--系统回顾和荟萃分析。

Saad Khalid, Laiba Imran, Muhammad Uzair, Javeria Tirmizi, Ayesha Khan, Suman Tashkil, Anas Adil
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引用次数: 0

摘要

背景:Olokizumab(OKZ)是一种针对白细胞介素受体-6的单克隆抗体,在最近对类风湿性关节炎(RA)患者进行的II期和III期试验中显示出了良好的前景。这项荟萃分析旨在评估Olokizumab治疗类风湿关节炎的有效性和安全性:我们在2023年3月之前检索了不同的数据库,以寻找随机对照试验,考察OKZ对使用抗肿瘤坏死因子或甲氨蝶呤治疗效果不佳的RA患者的各种结果的影响。数据通过Review Manager-v 5.4.1进行分析。计算了相对风险(RR)及95%置信区间:我们评估了五项试验的2761名患者,分为四个治疗组:60毫克OKZ,每周2次给药;64毫克,每周2次给药;64毫克,每周4次给药;120毫克,每周2次给药。根据 ACR 20、50 和 70 测量的临床反应显示,使用 OKZ 有显著的统计学改善。所有 4 个治疗组的疾病改善率均为 50%(OKZ 64 毫克,每周 2 次:RR=2.96,p结论:总之,与安慰剂相比,Olokizumab 能明显改善疾病活动,而且安全性良好。不过,还需要进一步开展更大规模和更长期的研究来证实这些发现。
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EFFICACY AND SAFETY OF OLOKIZUMAB IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS- A SYSTEMATIC REVIEW AND META-ANALYSIS.

Background: Olokizumab (OKZ) is a monoclonal antibody against the interleukin receptor-6 that has shown promise in recent phase II and III trials in patients of rheumatoid arthritis (RA). This meta-analysis aims to evaluate the efficacy and safety of Olokizumab in managing rheumatoid arthritis.

Methods: We searched different databases until March 2023 for randomized controlled trials inspecting the effects of OKZ on various outcomes in RA patients inadequately controlled with anti-TNF or methotrexate. Data were analyzed via Review Manager-v 5.4.1. Relative risks (RR) with 95% confidence intervals were calculated.

Results: We evaluated five trials with 2761 patients under four treatment groups: 60mg OKZ administered 2-weekly, 64mg 2-weekly, 64mg 4-weekly, and 120mg 2-weekly. Clinical response as measured by ACR 20, 50, and 70 showed statistically significant improvement with the use of OKZ. A 50% disease improvement was seen across all 4 treatment groups (OKZ 64 mg q2w: RR= 2.96, p<0.0001, OKZ 64mg q4w: RR= 3.06, p=0.0002, OKZ 60 mg q2w: RR=5.06, p=0.007, and OKZ 120mg q2w: RR= 3.63, p=0.04). Moreover, 20% and 70% improvements were also noted with OKZ in doses 64mg 2-weekly and 4-weekly. Disease remission, as indicated by DAS28 <2.6 was also significantly higher than placebo across all groups. Safety data showed comparable mortality rates in treatment and placebo groups (OKZ 64mg q2w: p=0.48, OKZ 64 mg q4w: p=0.93).

Conclusions: In conclusion, Olokizumab has shown significant improvement in disease activity compared to placebo with a favourable safety profile. However, further larger and longer-term studies are required to confirm these findings.

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