OBJECTIVE:To compare EuroQol 5-Dimensions (EQ-5D) utility and quality-adjusted life-years (QALYs) in patients with early, methotrexate (MTX) refractory rheumatoid arthritis (RA), randomised to addition of infliximab (IFX) or sulfasalazine and hydroxychloroquine (SSZ+HCQ). METHODS:RA-patients with symptoms <1 year were enrolled between 2002 and 2005 at 15 Swedish centres. After 3-4 months of MTX monotherapy, patients with a remaining DAS28>3.2 were randomised to addition of IFX or SSZ+HCQ and followed for 21 months. EQ-5D profiles were collected every 3 months. Between-group comparisons of utility change and accumulated QALYs were performed, using last observation carried forward (LOCF) following protocol breach. Missing data were imputed by linear interpolation or LOCF. Sensitivity analyses applying baseline observation carried forward (BOCF) or restricted to completers were conducted. RESULTS:Of 487 patients initially enrolled, 128 and 130 were randomised to IFX or SSZ+HCQ, respectively. Mean utility in the IFX and SSZ+HCQ groups increased from 0.52 (SD 0.27) and 0.55 (SD 0.27) at randomisation to 0.66 (SD 0.25) and 0.63 (SD 0.27) at 21 months (adjusted mean difference favouring IFX 0.04; 95% CI -0.01, 0.09; p=0.15). Average accumulated QALYs were 1.10 (SD 0.37) and 1.07 (SD 0.42) in the IFX and SSZ+HCQ groups, respectively (adjusted mean difference favouring IFX 0.07; 95%CI -0.01, 0.14; p=0.07). BOCF analysis showed similar results, while differences were reversed, though remained statistically non-significant among completers. Dropout rates in the IFX/SSZ+HCQ groups were 30%/43% (p=0.01). CONCLUSIONS:Comparing addition of IFX or SSZ+HCQ to MTX in active early RA, no statistically significant differences in utility or QALY gain could be detected over 21 months. TRIAL REGISTRATION:Registered in WHO database at the Karolinska University Hospital, number CT20080004.

译文

目的:比较早期甲氨蝶呤(MTX)难治性类风湿关节炎(RA)患者的EuroQol 5-Dimensions(EQ-5D)效用和质量调整生命年(QALYs),随机添加英夫利昔单抗(IFX)或柳氮磺吡啶和羟氯喹(SSZ HCQ)。
方法:2002年至2005年间,在瑞典的15个中心招募了症状<1年的RA患者。在MTX单药治疗3-4个月后,将DAS28> 3.2的患者随机添加IFX或SSZ HCQ,然后随访21个月。每3个月收集一次EQ-5D配置文件。进行了效用变化和累积QALY的组间比较,使用违反协议后的最新结转结果(LOCF)。缺失数据通过线性插值或LOCF估算。进行了敏感性分析,采用基线观察结转(BOCF)或仅限于完成者。
结果:在最初入组的487例患者中,分别有128例和130例被随机分配到IFX或SSZ HCQ。 IFX和SSZ HCQ组的平均效用从随机分配时的0.52(SD 0.27)和0.55(SD 0.27)增加到21个月时的0.66(SD 0.25)和0.63(SD 0.27)(调整后的平均差异有利于IFX 0.04; 95%CI -0.01,0.09; p = 0.15)。 IFX和SSZ HCQ组的平均累积QALYs分别为1.10(SD 0.37)和1.07(SD 0.42)(校正后的平均差异有利于IFX 0.07; 95%CI -0.01,0.14; p = 0.07)。 BOCF分析显示了相似的结果,尽管差异在统计学上没有显着差异,但差异却可以逆转。 IFX / SSZ HCQ组的辍学率为30%/ 43%(p = 0.01)。
结论:在活跃的早期RA中,将IFX或SSZ HCQ加入MTX的比较,在21个月内未发现效用或QALY增益有统计学意义的差异。
试验注册:在卡罗林斯卡大学医院的世界卫生组织数据库中注册,编号CT20080004。

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