Hetland M L, Lindegaard H M, Hansen A, Pødenphant J, Unkerskov J, Ringsdal V S, Østergaard M, Tarp U
DANBIO Registry, Department of Rheumatology, Hvidovre Hospital, Kettegård Alle 30, DK 2650, Hvidovre, Denmark.
Ann Rheum Dis. 2008 Jul;67(7):1023-6. doi: 10.1136/ard.2007.087262. Epub 2008 Feb 13.
Prescription practice for tumour necrosis factor alpha (TNFalpha) inhibitors has changed towards treating patients with lower disease activity.
To determine the trend in treatment response in cohorts of patients with rheumatoid arthritis who started TNFalpha inhibitor treatment between 2000 and 2005.
1813 patients with RA starting treatment with biological agents in 2000-5 were registered prospectively in the nationwide DANBIO Registry. Baseline disease activity and 12 months' treatment responses were determined in cohorts based on start year (2000/1; 2002; 2003; 2004; 2005).
Despite decreasing baseline disease activity from the 2000/2001 cohort to 2005 cohort (28-joint count Disease Activity Score (DAS28): from 5.9 to 5.3 (p<0.001)), the 12 months' DAS improvement increased from 1.8 units (2000/2001 cohort) to 2.2 units (2005 cohort) (p<0.001). The fraction with good EULAR response increased from 28% (2000/2001 cohort) to 50% (2005 cohort); the fraction with no response decreased from 29% (2000/2001 cohort) to 16% (2005 cohort). ACR20/50/70 response rates increased from 53%/31%/13% (2000/2001 cohort) to 69%/51%/30% (2005 cohort). After correction for withdrawals, treatment responses were lower, but patterns unchanged. One-year drug survival was for the 2000/2001 cohort: 73%, 2002: 62%, 2003: 67%, 2004: 70%, 2005: 69%.
From 2000 to 2005, significantly improved treatment responses to TNF inhibitors were seen in clinical practice despite decreasing baseline disease activity levels. This lends support to the less stringent prescription practice towards treating patients with lower disease activity that has been observed in several countries.
肿瘤坏死因子α(TNFα)抑制剂的处方实践已朝着治疗疾病活动度较低的患者转变。
确定2000年至2005年间开始使用TNFα抑制剂治疗的类风湿关节炎患者队列的治疗反应趋势。
2000 - 2005年开始使用生物制剂治疗的1813例类风湿关节炎患者前瞻性地登记在全国性的DANBIO注册中心。根据开始年份(2000/1;2002;2003;2004;2005)确定各队列的基线疾病活动度和12个月的治疗反应。
尽管从2000/2001队列到2005队列基线疾病活动度有所下降(28个关节计数疾病活动评分(DAS28):从5.9降至5.3(p<0.001)),但12个月的DAS改善从1.8个单位(2000/2001队列)增加到2.2个单位(2005队列)(p<0.001)。欧洲抗风湿病联盟(EULAR)良好反应的比例从28%(2000/2001队列)增加到50%(2005队列);无反应的比例从29%(2000/2001队列)降至16%(2005队列)。美国风湿病学会(ACR)20/50/70反应率从53%/31%/13%(2000/2001队列)增加到69%/51%/30%(2005队列)。校正退出情况后,治疗反应较低,但模式不变。2000/2001队列的一年药物生存率为73%,2002年为62%,2003年为67%,2004年为70%,2005年为69%。
从2000年到2005年,尽管基线疾病活动度水平下降,但临床实践中对TNF抑制剂的治疗反应显著改善。这支持了在一些国家观察到的对疾病活动度较低患者采用不那么严格的处方实践。