奈达单抗治疗强直性脊柱炎患者的实际保留率、有效性和安全性:LIBRA注册后安全性研究的第一年结果。

IF 0.8 4区 生物学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY Doklady Biochemistry and Biophysics Pub Date : 2024-08-28 DOI:10.1134/S1607672924701084
Sh. Erdes, V. I. Mazurov, I. Z. Gaydukova, O. N. Anoshenkova, I. B. Vinogradova, Yu. Yu. Grabovetskaya, S. Y. Davidian, N. A. Kiryukhina, O. E. Epifanova, L. V. Masneva, L. V. Menshikova, O. N. Mironenko, N. E. Nikulenkova, T. V. Povarova, A. N. Poliatika, R. R. Samigullina, A. E. Sizikov, I. N. Totrov, I. F. Umnova, J. V. Usacheva, A. L. Chudinov
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引用次数: 0

摘要

奈达单抗在治疗强直性脊柱炎患者的对照临床试验中显示出很高的疗效。本文介绍了在常规临床实践中使用奈达单抗的观察性研究结果:目的:评估在实际临床实践中使用奈达单抗治疗强直性脊柱炎患者的保留率和安全性。此外,还对奈达单抗在1年随访中的疗效进行了评估:2020 年 8 月至 2021 年 12 月期间,在俄罗斯联邦的 23 个中心招募患者参与研究。研究对象包括入组前已接受奈达单抗治疗的患者,因此首次就诊的临床和病史数据以回顾性方式录入,并在研究范围内收集治疗 12 周、24 周和 52 周的后续就诊数据。根据卡普兰-梅耶尔分析法计算药物存活率:研究纳入了 137 名(男性 93 名,女性 44 名)强直性脊柱炎患者。患者平均年龄为42.3(11.9)岁,34.3%的患者曾接受过bDMARD治疗,主要是TNF抑制剂。在分析期结束时(治疗 52 周),90.4%(95% CI,85.4-95.7)的患者继续接受奈达单抗治疗。在所有时间点,BASDAI和ASDAS-CRP的评分与基线相比均有统计学意义上的显著下降。患者对奈达单抗的耐受性良好;根据研究者的意见,7 例(5.1%)患者出现了与治疗相关的 AE。两名患者因不良反应(末端回肠炎和慢性结肠炎)而停止服用奈达单抗:在真实世界的临床实践中,奈达单抗的保留率很高,安全性良好,在第一年的治疗中疗效持续。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Real-World Retention Rate, Effectiveness, and Safety of Netakimab in the Treatment of Patients with Ankylosing Spondylitis: First Year Results of the LIBRA Post-Registration Safety Study

Netakimab has shown high efficacy in controlled clinical trials in the treatment of AS patients. This article presents results of an observational study of netakimab using in routine clinical practice.

To evaluate retention rates and safety of netakimab in patients with AS in real-world clinical practice. Additionally, the efficacy of netakimab was evaluated at 1-year follow-up.

Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included patients who were prescribed netakimab therapy before enrollment, so clinical and medical history data for the first visit were entered retrospectively, and following visits at 12, 24, and 52 weeks of therapy were collected within the study. Drug survival rate was calculated according to Kaplan–Meier analysis.

The study included 137 (93 men and 44 women) patients with AS. The average age of patients was 42.3 (11.9) years, 34.3% of patients had previously received therapy with bDMARD, mainly TNF inhibitors. At the end of the analyzed period (52 weeks of therapy), 90.4% (95% CI, 85.4-95.7) of patients continued treatment with netakimab. The BASDAI and ASDAS-CRP showed statistically significant decreases in scores from baseline at all time points. Netakimab was well tolerated by patients; AEs, related to therapy according to the investigator’s opinion, were reported in 7 (5.1%) patients. Two patients stopped taking netakimab due to AEs (terminal ileitis and chronic colitis).

In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy.

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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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