目的:在免疫介导的风湿性疾病(IMRD)中,持续治疗可作为长期治疗成功的替代指标.在先前对肿瘤坏死因子α抑制剂(TNF-α)的持久性比较中,发现皮下(SC)戈利木单抗的数据很少.这项研究的目的是对SCgolimumab在临床实践中的持久性进行系统评价,并将这些数据与IMRD中SCTNFis的长期开放标签扩展(OLE)试验的五年持久性估计进行背景化。
方法:PubMed,Embase,MEDLINE,和欧洲抗风湿病联盟(EULAR)的会议记录,美国风湿病学会(ACR),和国际药物经济学和结果研究学会(ISPOR)进行了搜索。如果对接受SCgolimumab治疗的IMRD患者进行了所有研究,如果他们报告了对golimumab的持久性数据,则将其纳入。
结果:在通过搜索确定的376个可用参考中,12项研究共4,910名患者符合纳入标准。此外,有9项OLE试验。在纳入的临床实践研究中,六个月后,一年,两年,还有三年,坚持治疗的患者比例从63%到91%,47%到80%,40%到77%,32%到67%,分别。在四项研究中,包括与其他生物制剂的比较,戈利木单抗在统计学上不低于或优于其他治疗方法,这一观察结果得到OLE试验未校正点估计值的间接比较的支持.
结论:本研究中回顾的数据表明,戈利木单抗可能比其他肿瘤坏死因子具有更高的持久性,这一观点得到来自随机对照试验(RCTs)的OLE持久性数据的间接比较的支持.此外,该研究提示,与未接受生物治疗的患者相比,接受生物治疗的患者的持久性可能较低,而与类风湿性关节炎和银屑病关节炎相比,轴性脊柱关节炎的持久性可能较高.
OBJECTIVE: 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.
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.
CONCLUSIONS: 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.