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肿瘤坏死因子-α抑制剂与司库奇尤单抗治疗强直性脊柱炎疗效的相关性Meta分析
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Abstract:
目的：系统性评价肿瘤坏死因子-α抑制剂(TNFi)与司库奇尤单抗(secukinumab)治疗强直性脊柱炎(ankylosing spondylitis, AS)疗效的相关性。方法：根据检索词在PubMed、Cochrane library、Embase三大数据库进行搜集，选取2022年4月20日前收录的所有论文，按照纳入排除标准筛选有关司库奇尤单抗治疗AS患者的药物试验，并收集两类患者在16周和52周时ASAS20和ASAS40的应答情况，RevMan5.4被用于对获得的数据进行处理。结果：5个随机对照试验和一个开放标签的单臂试验被纳入本研究，共计1654名患者，其中439例(26.5%)接受过TNFi治疗，1215例(73.5%)未接受过TNFi治疗。数据分析显示，ASAS20在16周和52周时的合并效应量分别为[OR = 1.41, 95%CI (1.00, 1.98), P = 0.05]和[OR = 1.37, 95%CI (0.93, 2.02), P = 0.11]，ASAS40在16周时为[OR = 1.47, 95%CI (0.44, 2.68), P = 0.20]，52周时为[OR = 1.51, 95%CI (1.07, 2.14), P = 0.02]。在亚组分析中，16周和52周时ASAS20分别为[OR = 1.76, 95%CI (1.14, 2.71), P = 0.01]和[OR = 1.72, 95%CI (1.07, 2.74), P = 0.02]，ASAS40分别为[OR = 1.97, 95%CI (1.24, 3.13), P = 0.004]和[OR = 1.91, 95%CI (1.25, 2.94), P = 0.003]。结论：既往有无TNFi暴露史与司库奇尤单抗的疗效相关，未接受过TNFi治疗的患者对司库奇尤单抗的治疗反应优于接受过TNFi治疗的AS患者。
Objective: To systematically evaluate the relationship between tumor necrosis factor-α inhibitors (TNFi) and secukinumab in the treatment of ankylosing spondylitis (AS). Methods: Three databases of PubMed, Cochrane library, and Embase were used for bibliography retrieval Clinical trials of secukinumab in patients with AS that were selected before April 20, 2022, according to the inclu-sion and exclusion criteria. Responses to ASAS20 and ASAS40 at 16-week and 52-week were col-lected, and processed by RevMan5.4 software. Results: Five randomized controlled trials and one open-label single-arm trial were included in this study, involving a total of 1654 patients, of whom 439 (26.5%) patients received TNFi and 1215 (73.5%) patients did not receive TNFi. The results of the data analysis showed that the combined effect sizes of ASAS20 at 16-week and 52-week were [OR = 1.41, 95%CI (1.00, 1.98), P = 0.05] and [OR = 1.37, 95%CI (0.93, 2.02), P = 0.11], respectively. The combined effect sizes of ASAS40 at 16-week and 52-week were [OR = 1.47, 95%CI (0.44, 2.68), P = 0.20] and [OR = 1.51, 95%CI (1.07, 2.14), P = 0.02], respectively. In subgroup analysis, the com-bined effect sizes of ASAS20 at 16-week and 52-week were [OR = 1.76, 95%CI (1.14, 2.71), P = 0.01] and [OR = 1.72, 95%CI (1.07, 2.74), P = 0.02], respectively. The combined effect sizes of ASAS40 at 16-week and 52-week were [OR = 1.97, 95%CI (1.24, 3.13), P = 0.004] and [OR = 1.91, 95%CI (1.25, 2.94), P = 0.003], respectively. Conclusions: Previous TNFi exposure was correlated with the efficacy of secukinumab. Patients who did not receive TNFi had a better therapeutic response to secuki-numab than patients who received TNFi therapy.
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