van der Heijde Désirée M, Revicki Dennis A, Gooch Katherine L, Wong Robert L, Kupper Hartmut, Harnam Neesha, Thompson Chris, Sieper Joachim
Department of Rheumatology, Leiden University Medical Center, Leiden, Leiden, The Netherlands.
Arthritis Res Ther. 2009;11(4):R124. doi: 10.1186/ar2790. Epub 2009 Aug 17.
We evaluated the three-year impact of adalimumab on patient-reported physical function and health-related quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS).
The Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) is an ongoing five-year study that included an initial 24-week, randomized, placebo-controlled, double-blind period, followed by open-label extension treatment with adalimumab. Clinical and HRQOL data collected for up to three years from ATLAS were used for these analyses. Patients were randomized to receive adalimumab 40 mg or placebo by subcutaneous injection every other week. Physical function was assessed by the Bath AS Functional Index (BASFI), as well as by the Short Form 36 (SF-36) Health Survey Physical Component Summary (PCS) and Physical Function subscale scores. HRQOL was assessed using the AS Quality of Life (ASQOL) questionnaire. Disease activity was assessed by the Bath AS Disease Activity Index (BASDAI).
Of 315 patients enrolled in ATLAS, 288 (91%) participated in an open-label adalimumab treatment extension and 82% provided three-year outcome data. During the 24-week double-blind phase, adalimumab-treated patients experienced significant improvement compared with placebo-treated patients in the BASDAI (P < 0.001), BASFI (P < 0.001), ASQOL (P < 0.001), and both the SF-36 PCS (P < 0.001) and Physical Function subscale (P < 0.001) scores, but not the SF-36 Mental Component Summary score (P = 0.181) and Mental Health subscale scores (P = 0.551). Mean changes from baseline through three years of adalimumab treatment were statistically significant for the BASDAI (change score: -3.9, P < 0.001), BASFI (change score: -29.6, P < 0.001), SF-36 PCS (change score: 11.6, P < 0.001), and Physical Function (change score: 23.3, P < 0.001). Comparable results were observed for the other SF-36 scores and for the ASQOL (all P < 0.001).
Adalimumab significantly improved disease activity, patient-reported physical function, and HRQOL. These benefits were maintained over three years of treatment in patients with AS.
我们评估了阿达木单抗对活动性强直性脊柱炎（AS）患者报告的身体功能和健康相关生活质量（HRQOL）结果的三年影响。
阿达木单抗评估AS长期疗效和安全性试验（ATLAS）是一项正在进行的为期五年的研究，包括最初24周的随机、安慰剂对照、双盲期，随后是阿达木单抗的开放标签扩展治疗。从ATLAS收集的长达三年的临床和HRQOL数据用于这些分析。患者被随机分组，每两周皮下注射一次40mg阿达木单抗或安慰剂。身体功能通过巴斯强直性脊柱炎功能指数（BASFI）以及简明健康调查问卷36项（SF-36）身体成分汇总（PCS）和身体功能分量表评分进行评估。HRQOL使用强直性脊柱炎生活质量（ASQOL）问卷进行评估。疾病活动通过巴斯强直性脊柱炎疾病活动指数（BASDAI）进行评估。
在ATLAS登记的315例患者中，288例（91%）参与了阿达木单抗开放标签治疗扩展，82%提供了三年的结果数据。在24周双盲期，与安慰剂治疗患者相比，接受阿达木单抗治疗的患者在BASDAI（P<0.001）、BASFI（P<0.001）、ASQOL（P<0.001）以及SF-36 PCS（P<0.001）和身体功能分量表（P<0.001）评分方面有显著改善，但在SF-36精神成分汇总评分（P = 0.181）和心理健康分量表评分（P = 0.551）方面没有改善。从基线到阿达木单抗治疗三年的平均变化在BASDAI（变化评分：-3.9，P<0.001）、BASFI（变化评分：-29.6，P<0.001）、SF-36 PCS（变化评分：11.6，P<0.001）和身体功能（变化评分：23.3，P<0.001）方面具有统计学意义。在其他SF-36评分和ASQOL方面也观察到了类似结果（所有P<0.001）。
阿达木单抗显著改善了疾病活动、患者报告的身体功能和HRQOL。这些益处在AS患者三年的治疗中得以维持。
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