在TNF阻断剂治疗轴性脊柱关节炎失败后,转换或改变生物疗法:ROC-SpA研究,一种随机对照研究协议
Elisa Dalix1, Christian Marcelli2, Theodora Bejan-Angoulvant3
1University Jean Monnet Saint-Etienne, Mines Saint-Etienne, INSERM, SAINBIOSE U1059, Saint-Etienne, France.
BMJ open
|September 11, 2024
概括
这项研究将抗IL-17疗法与第二种抗瘤亡因子 (TNF) 生物相比较,用于轴性脊柱关节炎 (axSpA) 患者,这些患者最初的抗TNF治疗失败了. 结果将指导未来的axSpA治疗建议.
科学领域:
- 风湿病学和免疫学
- 临床试验研究 临床试验研究
- 药理学 药理学是指药理学的学科.
背景情况:
- 轴性脊椎关节炎 (axSpA) 是一种慢性炎症状况,主要导致腰部疼痛.
- 非类固醇抗炎药物 (NSAIDs) 是第一线治疗;生物修饰性抗风湿药物 (bDMARDs) 用于不充分的反应.
- 最近的指导方针建议在抗TNF失败后替代bDMARDs,IL-17抑制显示出希望.
研究的目的:
- 为了比较抗-17 (IL-17) 策略与第二种抗瘤亡因子 (TNF) 生物疗法的疗效,在 axSpA 患者中,先前的抗TNF 治疗失败.
- 在axSpA.中对第一个抗TNF疗法的不充分反应后,确定更有效的治疗选择.
主要方法:
- 该ROC-SpA研究是一项前性,随机化,多中心,优越性,开放标签的IV期试验.
- 它将抗IL-17策略 (secukinumab或ixekizumab) 与第二个TNF阻断剂进行比较,比例为1:1.
- 纳入标准:活跃的axSpA (BASDAI>4或ASDAS>3.5) 与第一个抗TNF的3个月不充分的反应,与稳定的同时治疗.
主要成果:
- 主要结果是国际脊髓炎协会40 (ASAS40) 在第24周的反应评估.
- 二次结局包括12周和52周的ASAS40,以及12周,24周和52周的其他临床评分 (ASAS20,部分缓解,ASDAS重大改善).
- 药物和抗药物度将在基线和12周,24周和52周测量.
结论:
- 这项试验旨在提供关于axSpA患者最佳治疗顺序的关键数据.
- 这些发现可能会影响国际建议在抗TNF失败后管理axSpA.
- 该研究已注册 (NCT03445845, EudraCT2017-004700-22) 结果将被广泛传播.
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