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TNF 抑制剂转换治疗强直性脊柱炎的疗效:来自 NOR-DMARD 登记处的数据。

Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register.

机构信息

Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

出版信息

Ann Rheum Dis. 2011 Jan;70(1):157-63. doi: 10.1136/ard.2010.131797. Epub 2010 Nov 9.

DOI:10.1136/ard.2010.131797
PMID:21062852
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.

摘要

目的

评估强直性脊柱炎(AS)患者转换使用第二种肿瘤坏死因子抑制剂(TNFi)的疗效。

方法

数据来自挪威一项正在进行的纵向观察性多中心研究。该研究纳入了初治使用 TNFi 的抗 TNF 初治 AS 患者,以及这些患者中使用第二种 TNFi 的情况。比较了转换组和非转换组以及转换组内(第一和第二种 TNFi)的疗效数据和 2 年药物生存率。

结果

共纳入 514 例抗 TNF 初治 AS 患者,77 例患者转换使用第二种 TNFi,437 例患者未转换。非转换组使用依那西普、英夫利昔单抗和阿达木单抗的比例分别为 53%、32%和 15%,转换组中第一和第二种 TNFi 的比例分别为 42%、53%和 5%和 40%、23%和 36%。转换的原因分别为:30 例疗效欠佳(IR),44 例不良事件(AE),3 例未报告。两组基线疾病活动度相似。非转换组中 49%和 38%的患者在 3 个月时达到 BASDAI50 和 ASAS40 缓解,转换组中第一次 TNFi 后分别为 25%和 30%,第二次 TNFi 后分别为 28%和 31%。转换组第二次 TNFi 治疗 3 个月时的疾病活动度水平高于非转换组。转换组第二次 TNFi 停药率高于非转换组(p=0.001)。IR 和 AE 导致的转换组之间,第二种 TNFi 的疗效无差异。

结论

本研究证实,在 AS 中转换使用第二种 TNFi 可能是有效的,与类风湿关节炎一样有用,尽管总体疗效似乎略低于非转换组。

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