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Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

机译:在免疫介导的风湿性疾病中坚持使用戈利木单抗:类风湿性关节炎,轴突性脊柱关节炎和银屑病关节炎的真实证据的系统回顾

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Purpose: In immune-mediated rheumatic diseases (IMRDs), persistence to treatment may be used as a surrogate marker for long-term treatment success. In previous comparisons of persistence to tumor necrosis factor α inhibitors (TNFis), a paucity of data for subcutaneous (SC) golimumab was identified. The aim of this study was to conduct a systematic review of persistence to SC golimumab in clinical practice and contextualize these data with five-year persistence estimates from long-term open-label extension (OLE) trials of SC TNFis in IMRDs. Patients and methods: PubMed, Embase, MEDLINE, and conference proceedings from European League Against Rheumatism (EULAR), American College of Rheumatology (ACR), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) were searched. All studies on patients treated with SC golimumab for IMRD were included if they reported data on the persistence to golimumab. Results: Of 376 available references identified through the searches, 12 studies with a total of 4,910 patients met the inclusion criteria. Furthermore, nine OLE trials were available. Among the included studies from clinical practice, at six months, one year, two years, and three years, the proportion of patients persistent to treatment ranged from 63% to 91%, 47% to 80%, 40% to 77%, and 32% to 67%, respectively. In the four studies that included comparisons to other biologics, golimumab was either statistically noninferior or statistically superior to other treatments, an observation that was supported by indirect comparisons of unadjusted point estimates of OLE trials. Conclusion: The data reviewed in this study indicate that golimumab may have higher persistence than other TNFis, a notion that is supported by indirect comparisons of persistence data from OLEs of randomized controlled trials (RCTs). Furthermore, the study suggests that persistence may be lower in biologic-experienced compared with biologic-naive patients and higher in axial spondyloarthritis compared with rheumatoid arthritis and psoriatic arthritis.
机译:目的:在免疫介导的风湿性疾病(IMRD)中,对治疗的持久性可以用作长期治疗成功的替代指标。在对肿瘤坏死因子α抑制剂(TNFis)的持久性进行的先前比较中,发现皮下(SC)戈利木单抗的数据很少。这项研究的目的是在临床实践中对SC戈利木单抗的持久性进行系统评价,并将这些数据与来自IMRD中SC TNFis的长期开放标签扩展(OLE)试验的五年持久性评估结合起来。患者和方法:检索了欧洲风湿病联盟(EULAR),美国风湿病学院(ACR)和国际药物经济学和结果研究协会(ISPOR)的PubMed,Embase,MEDLINE和会议记录。如果报道了对戈利木单抗持续性的数据,则所有接受SC戈利木单抗IMRD治疗的患者的研究均包括在内。结果:在通过搜索确定的376个可用参考文献中,有12项研究(共4,910名患者)符合纳入标准。此外,还提供了9个OLE试验。在临床实践中纳入的研究中,在六个月,一年,两年和三年时,坚持治疗的患者比例为63%至91%,47%至80%,40%至77%和分别为32%至67%。在包括与其他生物制剂的比较的四项研究中,戈利木单抗在统计学上不逊于其他统计学或在统计学上优于其他治疗,这一观察结果得到对OLE试验未调整点估计值的间接比较的支持。结论:本研究回顾的数据表明,戈利木单抗可能比其他TNFis具有更高的持久性,这一观点得到了随机对照试验(RCT)OLE的持久性数据的间接比较的支持。此外,研究表明,与未接触过生物的患者相比,具有生物学经验的患者的持久性可能较低,而与类风湿性关节炎和银屑病性关节炎相比,轴突性脊柱关节炎的持久性可能更高。

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