强直性脊柱炎患者转换TNF抑制剂的疗效: 来自NOR-DMARD登记系统的数据

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Ann Rheum Dis. 2011 Jan;70(1):157-63. Epub 2010 Nov 9. Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register. Lie E, van der Heijde D, Uhlig T, Mikkelsen K, Rødevand E, Koldingsnes W, Kaufmann C, Kvien TK. Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. elisabeth_lie@yahoo.no Abstract OBJECTIVE: To assess the effectiveness of switching to a second tumour necrosis factor inhibitor (TNFi) in patients with ankylosing spondylitis (AS). METHODS: Data were extracted from an ongoing longitudinal observational multicentre study in Norway. This study included anti-TNF naïve patients with AS starting treatment with a TNFi as well as treatment with a second TNFi in these same patients. Effectiveness data and 2-year drug survival were compared between switchers and non-switchers and within switchers (first and second TNFi). RESULTS: 514 anti-TNF naïve patients with AS were included; 77 patients switched to a second TNFi while 437 patients did not switch. The percentages of non-switchers using etanercept, infliximab or adalimumab were 53%, 32% and 15%, and the percentages of first and second TNFi in the switchers were 42%, 53% and 5% and 40%, 23% and 36%, respectively. The reason for switching was insufficient response (IR) in 30, adverse events (AEs) in 44 and not reported in 3 patients. Baseline disease activity was similar between the groups. Three-month BASDAI 50 and ASAS 40 responses were achieved by 49% and 38% of non-switchers, by 25% and 30% of switchers after the first TNFi and by 28% and 31% after the second TNFi. The 3-month disease activity level was higher for switchers on the second TNFi than for non-switchers. Drug withdrawal rate was higher during the second TNFi among switchers than for non-switchers (p=0.001). No difference was found in the effectiveness of the second TNFi between switchers due to IR and AE. CONCLUSION: This study confirms that switching to a second TNFi can be effective in AS and can be as useful as in rheumatoid arthritis, although overall effectiveness seems to be somewhat lower than in non-switchers.

强直性脊柱炎患者转换TNF抑制剂的疗效: 来自NOR-DMARD登记系统的数据 Lie E, van der Heijde D, Otten MH, Prince FH Ann Rheum Dis. 2011 Jan;70(1):157-63. 目的:评价强直性脊柱炎 (AS) 患者转换到第二种肿瘤坏死因子抑制剂(TNFi)的疗效。 方法:从挪威正在进行的纵向观察多中心研究中提取数据。该研究纳入未用过anti-TNF治疗的AS患者，开始接受TNFi以及之后转换第二种TNFi治疗。比较转换病例和非转换病例以及转换病例间（第一个和第二个TNFi）的有效性数据和2年药物存活率。 结果: 共入选514 未用过抗-TNF的AS患者;77例患者转换用第二种TNFi， 437例没有转换。应用依那昔普、英夫利昔单抗或阿达木单抗患者未转换的比例分别为53%、32%和15%,上述3药作为第一或第二个TNFi在转换病例中的比例分别为 42%和53%，5%和40%,以及23%和36%。转换的原因中，疗效不足 (IR)30例,不良事件(AEs) 44例，其余 3例原因不明。各组间基线水平的疾病活动度相似。3个月时BASDAI 50和ASAS40反应在未转换患者为49%和38%，第一个TNFi转换后为25%的30%,第二个TNFi转换后为 28%和31%。停药率在TNFi转换组也明显增高 (p = 0.001)。由于IR和AE而转换TNFi的患者疗效无差异。 结论:本研究证实, TNFi转换对AS和类风湿性关节炎有效,虽然整体有效性似乎比不转换者稍低。