奈达单抗对活动性强直性脊柱炎患者的长期疗效和安全性:BCD-085-5/ASTERA 国际多中心随机双盲 III 期临床试验三年的结果

V. I. Mazurov, S. Erdes, I. Z. Gaydukova, T. Dubinina, A. Pristrom, E. Kunder, N. Soroka, A. Kastanayan, T. Povarova, E. Zhugrova, T. Plaksina, P. Shesternya, T. Kropotina, O. Antipova, E. Smolyarchuk, O. A. Tsyupa, D. Abdulganieva, S. A. Lapshina, D. Krechikova, I. G. Gordeev, O. Nesmeyanova, E. Ilivanova, A. Strelkova, V. V. Tyrenko, E. A. Mikhailova, A. Eremeeva
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引用次数: 0

摘要

本文介绍了强直性脊柱炎(AS)患者使用奈达单抗(NTK)三年的结果,这是BCD-085-5/ATERA III期研究的一部分。BCD-085-5/ATERA--双盲、多中心、随机III期临床试验,入组患者均为活动性强直性脊柱炎患者(BASDAI≥4),背痛强度在数字评分表中≥4,对非甾体抗炎药或生物制剂药物无效或不耐受。共有 228 名患者按 1:1 的比例被随机分配到 NTK 组或安慰剂/NTK 组。从第16周开始,未达到ASAS20(根据ASAS标准改善20%)的患者接受NTK 120毫克,每两周一次,采用开放标签疗法。在第52周NTK组和第68周安慰剂/NTK组获得ASAS20反应的患者继续接受NTK治疗(每2周一次,每次120毫克),直到第156周NTK组和第172周安慰剂/NTK组。在使用NTK的三年期间,大多数患者的强直性脊柱炎活动持续下降(根据ASDAS-CRP、BASDAI),对治疗有持续反应(ASAS20/40、ASAS5/6)。大多数不良反应为轻度至中度。36.7%的患者出现了不良反应,主要是实验室异常、血液和淋巴系统异常以及感染性并发症。大多数强直性脊柱炎患者服用NTK三年后仍能保持临床疗效,没有明显的反应消失。NTK的耐受性良好,安全性也保持良好。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-term efficacy and safety of netakimab in patients with active ankylosing spondylitis: results of three years of use in the international multicentre, randomized, double-blind, phase III clinical trial BCD-085-5/ASTERA
The article presents the results of the three-year use of netakimab (NTK) in patients with ankylosing spondylitis (AS) as part of the phase III BCD-085-5/ASTERA study.Objective: to evaluate the long-term efficacy and safety of NTK over a three-year period in patients with active AS.Material and methods. BCD-085-5/ASTERA – double-blind, multicenter, randomized phase III clinical trial that enrolled patients with active AS (BASDAI ≥4) and a back pain intensity ≥4 on a numeric rating scale with inefficacy or intolerance of non-steroidal anti-inflammatory drugs or biologic drugs. A total of 228 patients were randomized in a 1:1 ratio and assigned to either the NTK group or the placebo/NTK group. Starting at week 16, patients who did not achieve ASAS20 (20% improvement according to ASAS criteria) received NTK 120 mg once every 2 weeks in an open-label regimen. Patients who achieved ASAS20 response at week 52 in the NTK group and week 68 in the placebo/NTK group continued to receive NTK (120 mg every 2 weeks) until week 156 in the NTK group and until week 172 in the placebo/NTK group.Results and discussion. Over the course of three years of NTK use, most patients experienced a sustained decline in AS activity (according to ASDAS-CRP, BASDAI) with sustained response (ASAS20/40, ASAS5/6) to therapy. Most adverse events reported were mild to moderate. 36.7% of patients had adverse events, which were mainly laboratory abnormalities, blood and lymphatic system abnormalities and infectious complications.Conclusion. The clinical effect of NTK was maintained in most patients with AS over a three-year period, with no significant loss of response. NTK was well tolerated and the safety profile remained favorable.
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