在SARS-CoV-2大流行期间,对类风湿关节炎患者从抗B细胞疗法转为奥洛珠单抗疗法的疗效和安全性进行的一项为期12周的开放标签、非干预性研究的结果。

IF 0.8 4区 生物学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY Doklady Biochemistry and Biophysics Pub Date : 2024-07-01 DOI:10.1134/S1607672924701060
A. A. Akimova, N. E. Banshchikova, A. E. Sizikov, A. A. Mullagaliev, E. A. Letyagina, N. A. Ilina, Y. D. Kurochkina, Y. B. Ubshaeva, V. O. Omelchenko, O. A. Chumasova, N. S. Shkaruba, M. A. Korolev
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引用次数: 0

摘要

摘要-COVID-19大流行极大地改变了人们对免疫炎症性风湿病(IRD)疗法安全性的认识。这主要是由于一些基本的改善病情抗风湿药物(DMARDs)和基因工程生物药物(生物 DMARDs 或生物制剂)对新型冠状病毒感染的过程和结果产生了负面影响。一些研究表明,抗 B 细胞疗法(利妥昔单抗)会在统计学上显著增加发生严重 COVID-19 的风险,并增加死亡率。与此同时,对实际临床实践数据的分析决定了有必要对某些类别生物制剂的使用制定一系列限制,并寻找替代治疗方案,以保持对疾病活动的控制:研究目的:该研究旨在评估Artlegia®(奥洛珠单抗)药物(皮下注射溶液,160毫克/毫升-0.4毫升,俄罗斯R-Pharm股份公司生产)在COVID-19大流行期间换用利妥昔单抗后在实际临床实践中治疗类风湿性关节炎患者的疗效和安全性:研究对象包括 14 名确诊为类风湿性关节炎(RA)的患者,这些患者曾接受过利妥昔单抗治疗,剂量为 1000-500 毫克,两次间隔 2 周,至少接受过一个疗程的治疗。随着RA病情恶化,患者在使用标准DMARDs的基础上改用olokizumab。在换药后的第0、4、8和12周,用VAS量表评估疼痛的严重程度、关节触痛和肿胀的数量(TJC28和SJC28)、急性期炎症标志物的水平、DAS28(疾病活动评分)、血沉、CRP、CDAI(临床活动指数)和功能状态指数HAQ(健康评估问卷),并评估治疗的安全性:数据分析采用中位值(Me)。使用奥洛单抗(Artlegia®)治疗8周和12周后,发现TJC28明显下降(Me基线=10,Me 8周=4,Me 12周=4,P<0.05),治疗4周、8周和12周后,发现TSC28下降(Me基线=9,Me 4周=3.5,Me 8周=2.5,Me 12周=2.0,P<0.05)。实验室炎症指标显示,治疗 4 周后 CRP 和 ESR 水平下降(CRP:Me4 周 = 21,Me4 周 = 1,p < 0.05;ESR:Mesno = 31,Me4 周 = 7,p < 0.05)。在第 8 周和第 12 周,积极的动态变化持续存在(CRP:Me 8 周 = 1,Me 12 周 = 0;ESR:Me 8 周 = 4,Me 12 周 = 5)。无论初始值如何,第 4 周的 CRP 水平都在正常范围内。与基线相比,每个评估期的所有活动指数从第 4 周开始都有所改善:DAS28-ESR:我的基线 = 5.52,我的第 4 周 = 3.59,我的第 8 周 = 3.33,我的第 12 周 = 3.22,P < 0.05;DAS28CRP:我的基线 = 5.39,我的第 4 周 = 3.71,我的第 8 周 = 3.35,我的第 12 周 = 3.45,P < 0.05;CDAI:我的基线 = 28.5,我的第 4 周 = 18.0,我的第 8 周 = 16.5,我的第 12 周 = 16.0,P < 0.05。到第 8 周时,所有患者的疼痛都有所减轻(VAS 量表)。根据 HAQ 指数,患者的功能状态仅在研究第 12 周时才出现显著下降:基线 = 1.62,12 周 = 1.31,P < 0.05:研究发现,在 COVID-19 大流行期间,从利妥昔单抗转用奥洛珠单抗是有效和安全的。
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Results of a 12-Week Open-Label, Non-Interventional Study of the Efficacy and Safety of Olokizumab Therapy in Patients with Rheumatoid Arthritis after Switching from Anti-B-Cell Therapy during the SARS-CoV-2 Pandemic

The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic disease-modifying antirheumatic drugs (DMARDs) and genetically engineered biological drugs (biological DMARDs, or biologics) on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biologics and to search for alternative therapy programs to maintain control over disease activity.

Purpose of the study. The purpose of the study was to evaluate the efficacy and safety of the drug Artlegia® (olokizumab), solution for subcutaneous injection, 160 mg/ml-0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheumatoid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic.

Materials and methods. The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000–500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. On weeks 0, 4, 8, and 12 after the switch, the severity of pain was assessed on the VAS scale, the number of tender and swollen joints (TJC28 and SJC28), the level of acute-phase inflammation markers, the DAS28 (disease activity score), ESR, CRP, CDAI (clinical activity index), and the functional state index HAQ (Health Assessment Questionnaire) were determined, as well as the safety profile of therapy was assessed.

Results. Data analysis was performed using median values (Me) were used for data analysis. A significant decrease in TJC28 was detected after 8 and 12 weeks of treatment with olokizumab (Artlegia®) (Me baseline = 10, Me 8 weeks = 4, Me 12 weeks = 4, p < 0.05) and a decrease in TSC28 was detected after 4, 8, and 12 weeks of treatment (Me baseline = 9, Me 4 weeks = 3.5, Me 8 weeks = 2.5, Me 12 weeks = 2.0, p < 0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me4 weeks = 21, Me4 weeks = 1, p < 0.05, ESR: Mesno = 31, Me4 weeks = 7, p < 0.05). Positive dynamics persisted on 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0; ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by week 4 became within the normal range, regardless of the initial values. All activity indices improved from week 4 in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22, p < 0.05; DAS28CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45, p < 0.05; CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0, p < 0.05. All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by week 12 of the study: Me baseline = 1.62, Me 12 weeks = 1.31, p < 0.05.

Conclusions. The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.

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来源期刊
Doklady Biochemistry and Biophysics
Doklady Biochemistry and Biophysics 生物-生化与分子生物学
CiteScore
1.60
自引率
12.50%
发文量
68
审稿时长
6-12 weeks
期刊介绍: Doklady Biochemistry and Biophysics is a journal consisting of English translations of articles published in Russian in biochemistry and biophysics sections of the Russian-language journal Doklady Akademii Nauk. The journal''s goal is to publish the most significant new research in biochemistry and biophysics carried out in Russia today or in collaboration with Russian authors. The journal accepts only articles in the Russian language that are submitted or recommended by acting Russian or foreign members of the Russian Academy of Sciences. The journal does not accept direct submissions in English.
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