在实际临床实践中类风湿关节炎患者的管理:从白细胞介素6受体抑制剂转向白细胞介素6抑制剂(olokizumab)

A. A. Baranov, I. Vinogradova, O. Anoshenkova, O. Antipova, E. Bogdanova, Y. Y. Grabovetskaya, E. Ilivanova, A. Kalyagin, I. Kushnir, N. Lapkina, M. V. Mokrousova, O. Nesmeyanova, N. M. Nikitina, P. Shesternya, N. Yudina, E. Feist, E. Nasonov
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引用次数: 1

摘要

的目标。切换到具有相同作用模式的另一种生物制剂为类风湿关节炎(RA)患者的长期治疗提供了更大的机会。在临床实践中,特别是在COVID-19大流行的背景下,这种转换也会因非医疗原因而发生。然而,没有关于从白细胞介素6 (IL-6)受体(R)抑制剂转换为直接IL-6抑制剂的信息。目的:评估在IL-6R抑制剂(tocilizumab (TOC), sarilumab (SAR))切换到olokizumab (OKZ)后,RA患者治疗的有效性和安全性,原因与疗效丧失或不良事件无关。材料和方法。在这项回顾性队列研究中,疗效参数和常规生化数据采用描述性统计分析-连续参数的平均值具有标准偏差,二元变量的绝对和相对频率。根据患者档案报告不良事件(AE)。采用配对t检验确定访视分析变量的统计学显著性和变化情况。采用Fisher精确检验或卡方检验比较改善/无变化患者与恶化患者的比例。所有检验均为双侧检验,p<0.050被认为具有统计学意义。由于这是一项观察性研究,没有预先规定统计标准。结果。我们分析了110例每4周皮下注射64 mg OKZ的RA患者在5次就诊期间获得的结果(转换前两次就诊,转换后两次就诊)。大多数患者为女性(79.1%),70%的患者类风湿因子和环瓜氨酸肽抗体均阳性。RA平均持续时间为11 [6];16年,既往治疗时间44年[27;62]月,转换至OKZ的平均间隔时间为35 [31];68)天。这种相对较长的间隔导致DAS28-ESR(疾病活动评分28,测定红细胞沉降率)从2.4 [1.9;3.0]至2.6 [2.1;3.5], DAS28- crp (DAS28随c反应蛋白水平测定)从2.8 [2.0;3.3]至2.9 [2.2;[4.0](接受联合治疗和单一治疗的患者趋势相似)。转换后RA症状及各项指标均较转换就诊时有所改善(部分症状及指标甚至较稳定治疗期有明显改善,如DAS28-CRP为2.4 [2.0;整体组为3.1,2.4 [2.1;2.7]单药治疗组)。仅有7例(6.4%)患者发生不良反应,其中1例(0.9%)(疱疹感染加重)被认为是严重的。最常见的ae是关节痛和轻度短暂性白细胞减少(各2例)。没有人员死亡。结论。在切换两种方案后,OKZ有效地维持了RA的缓解/低活性:作为疾病改善抗风湿药的附加治疗和单一治疗,并且没有引起任何额外的安全性问题。当切换到OKZ之前的时间间隔接近IL-6R抑制剂说明书中所指示的时间间隔时,报告的最佳结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Management of patients with rheumatoid arthritis in real clinical practice: Switching from interleukin 6 receptor inhibitors to interleukin 6 inhibitor (olokizumab)
Aim. Switching to another biologic with the same mode of action provides greater opportunity for long-term management of patients with rheumatoid arthritis (RA). In clinical practice, especially in the context of the COVID-19 pandemic, such switching occurred for non-medical reasons as well. However, there is no information about switching from interleukin 6 (IL-6) receptor (R) inhibitor to direct IL-6 inhibitor. Objective – to assess the efficacy and safety of therapy in RA patients, after switching from IL-6R inhibitors (tocilizumab (TOC), sarilumab (SAR)) to olokizumab (OKZ) for reasons not related to the loss of their efficacy or adverse events. Material and methods. In this retrospective cohort study efficacy parameters and routine biochemical data were analyzed using descriptive statistics – mean values with standard deviation for continuous parameters and absolute and relative frequency for binary variables. Adverse events (AE) were reported according to patient’s files. The statistical significance and changes of the analyzed variables by visits were determined using paired t-test. Fisher’s exact test or chi-square test was used to compare the proportion of patients with improvement/no change and of patients with worsening. All tests were 2-sided, and p<0.050 was considered statistically significant. As this was an observational study, the statistical criteria have not been pre-specified. Results. We analyzed results obtained during 5 visits (2 visits before switching, switching visit and 2 visits after switching) in 110 RA patients who switched to OKZ 64 mg every 4 weeks subcutaneously (SC). Most patients (79.1%) were women, and 70% of patients were both positive by rheumatoid factor and antibodies to cyclic citrullinated peptide. Mean RA duration was 11 [6; 16] years, previous treatment duration was 44 [27; 62] months and mean interval before switching to OKZ was 35 [31; 68] days. This relatively long interval led to an increase in DAS28-ESR (Disease Activity Score 28 with determination of erythrocyte sedimentation rate) from 2.4 [1.9; 3.0] to 2.6 [2.1; 3.5] and DAS28-CRP (DAS28 with determination of C-reactive protein level) from 2.8 [2.0; 3.3] to 2.9 [2.2; 4.0] (the trends were similar in patients who received combined therapy and monotherapy). After switching, all of RA symptoms and indexes have been improved compared with the switching visit (some of them were significantly better even compared with stable therapy period e. g. DAS28-CRP was 2.4 [2.0; 3.1] in the overall group and 2.4 [2.1; 2.7] in the monotherapy group). AEs were registered in only 7 (6.4%) patients, of which 1 (0.9%) case (an exacerbation of herpes infection) was considered as serious. The most frequent AEs were arthralgia and mild transient leukopenia (2 patients each). There were no deaths. Conclusion. OKZ effectively maintained remission/low activity of RA after switching in both regimens: as add-on to disease modifying anti-rheumatic drugs and as monotherapy, and did not cause any additional safety concerns. The optimal results were reported when intervals before switching to OKZ were closer to those indicated in the instructions for IL-6R inhibitors.
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