ixekizumab在真实临床实践条件下治疗脊柱炎的有效性和安全性

A. D. Meshkov, V. S. Ostapenko, V. S. Pykhtina
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In the AS group (4 males and 5 females), the median age at the therapy initiation was 34 [32; 41.5] years and in the PA group (11 males and 6 females — 40 [32.5; 48.5] years. Failure or intolerance of the standard therapy was reported in all patients. Prior to ixekizumab treatment, most patients did not receive targeted therapies. Of 27 patients, 4 received genetically engineered biological drugs / targeted synthesized drugs which failed to achieve remission / low disease activity. In the AS group, the elevated levels of CRP were revealed in 7 (77.8%) patients, ASDAS demonstrated the presence of disease activity in all patients. According to BASDAI, disease activity was recorded in 7 (77.8%) cases. During the treatment, there was a downtrend in the percentage of patients with high disease activity as shown by ASDAS and BASDAI scores, as well as in the percentage of patients with elevated levels of CRP, while the BASDAI values were statistically significant (p=0.031). 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引用次数: 0

摘要

目的:评价ixekizumab在实际临床中治疗强直性脊柱炎(AS)和银屑病关节炎(PA)的疗效和安全性。患者和方法:这项回顾性研究纳入了2021年2月至2022年4月接受ixekizumab治疗的AS和PA患者。每3-6个月评估一次疾病活动性,使用AS的BASDAI和ASDAS评分和PA的DAPSA和PASI评分。c反应蛋白(CRP)作为疾病活动性的血清学标志物。结果:分析了27例患者的数据,其中10例为AS, 17例为- PA。对所有患者进行治疗安全性评估,并将9例AS和16例PA患者的资料纳入治疗疗效分析。在AS组(4男5女)中,治疗开始时的中位年龄为34岁[32;41.5岁,而PA组(11名男性,6名女性)为40岁[32.5;48.5)年。所有患者均报告了标准治疗的失败或不耐受。在ixekizumab治疗之前,大多数患者未接受靶向治疗。在27例患者中,4例患者接受了基因工程生物药物/靶向合成药物治疗,但未能达到缓解/低疾病活动度。在AS组中,7例(77.8%)患者CRP水平升高,ASDAS显示所有患者均存在疾病活动性。根据BASDAI的数据,有7例(77.8%)病例记录有疾病活动。治疗过程中,ASDAS和BASDAI评分显示疾病活动度高的患者比例呈下降趋势,CRP水平升高的患者比例呈下降趋势,BASDAI值有统计学意义(p=0.031)。在PA组中,62.5%的患者报告CRP水平升高,75.0%的患者报告DAPSA评分为中度至高活性。治疗后,DAPSA评分较高、CRP水平升高的患者比例有所下降,但变化无统计学意义。7.4%的患者报告有副作用,但未发生严重不良事件。结论:根据我们的数据,在实际临床实践中,ixekizumab在治疗PA和AS方面显示出有效性和安全性。关键词:ixekizumab,真实临床实践,银屑病关节炎,强直性脊柱炎,基因工程生物药物。引文:Meshkov a.d., Ostapenko V.S., Pykhtina V.S.真实临床实践条件下ixekizumab治疗脊柱炎的疗效和安全性。俄罗斯医学调查。2023;7(3):137-143(俄文)。Doi: 10.32364/2587-6821- 2023-7-3-137-143。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The efficacy and safety of ixekizumab in the treatment of spondyloarthritis under the conditions of real clinical practice
Aim: to assess the efficacy and safety of ixekizumab in the treatment of ankylosing spondyloarthritis (AS) and psoriatic arthritis (PA) in real clinical practice. Patients and Methods: this retrospective study included patients with AS and PA who received ixekizumab therapy from February 2021 to April 2022. Disease activity was evaluated every 3–6 months, using BASDAI and ASDAS scores for AS and DAPSA и PASI scores for PA. C-reactive protein (CRP) served as a serologic marker of disease activity. Results: the analysis included the data received for 27 patients, of whom 10 persons had AS and 17 — PA. The safety of treatment was assessed in all patients, and the data of 9 AS and 16 PA patients were included in the analysis of the treatment efficacy. In the AS group (4 males and 5 females), the median age at the therapy initiation was 34 [32; 41.5] years and in the PA group (11 males and 6 females — 40 [32.5; 48.5] years. Failure or intolerance of the standard therapy was reported in all patients. Prior to ixekizumab treatment, most patients did not receive targeted therapies. Of 27 patients, 4 received genetically engineered biological drugs / targeted synthesized drugs which failed to achieve remission / low disease activity. In the AS group, the elevated levels of CRP were revealed in 7 (77.8%) patients, ASDAS demonstrated the presence of disease activity in all patients. According to BASDAI, disease activity was recorded in 7 (77.8%) cases. During the treatment, there was a downtrend in the percentage of patients with high disease activity as shown by ASDAS and BASDAI scores, as well as in the percentage of patients with elevated levels of CRP, while the BASDAI values were statistically significant (p=0.031). In the PA group, elevated CRP levels were reported in 62.5% of patients, and DAPSA scores represented moderate of high activity in 75.0% of patients. As a result of the treatment, there was a decrease in the percentage of patients with higher DAPSA scores and elevated CRP levels, but the changes did not achieve statistical significance. Side effects were reported in 7.4% of patients, but there were no serious adverse events. Conclusion: acording to our data ixekizumab has shown efficacy and safety in the treatment of PA and AS in real clinical practice. KEYWORDS: ixekizumab, real clinical practice, psoriatic arthritis, ankylosing spondyloarthritis, genetically engineered biological drugs. FOR CITATION: Meshkov A.D., Ostapenko V.S., Pykhtina V.S. The efficacy and safety of ixekizumab in the treatment of spondyloarthritis under the conditions of real clinical practice. Russian Medical Inquiry. 2023;7(3):137–143 (in Russ.). DOI: 10.32364/2587-6821- 2023-7-3-137-143.
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