Rudwaleit M, Listing J, Brandt J, Braun J, Sieper J
Rheumatology, Department of Medicine, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
Ann Rheum Dis. 2004 Jun;63(6):665-70. doi: 10.1136/ard.2003.016386. Epub 2004 Mar 22.
TNFalpha blockers have been shown to be highly efficacious in patients with active ankylosing spondylitis (AS).
To identify parameters predicting the clinical response to TNF blockers in AS.
Patients with active AS participated in two placebo controlled, randomised trials conducted in Germany with infliximab (n = 69) and etanercept (n = 30), respectively. For inclusion in either trial patients had to have high disease activity (BASDAI >or=4) and a spinal pain score (numerical rating scale 0-10) >or=4 despite treatment with NSAIDs. A major clinical response was defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 12 weeks' treatment with active drug. Logistic regression likelihood ratio tests (univariate and multivariate), Student's t test, and chi(2) tests were performed.
Univariate analysis showed the following to be predictors of a major response (BASDAI 50) to treatment: shorter disease duration (p = 0.003); lower BASFI (p = 0.007); younger age (p = 0.009); raised ESR (p = 0.033); raised CRP (p = 0.035). After adjustment for disease duration, BASFI, ESR, and CRP, but not age, remained significantly associated. After adjustment for disease duration and for BASFI, ESR, CRP, and in addition, a higher BASDAI were significantly associated with response. The best multivariate model built by stepwise regression contained the covariables disease duration, BASFI, BASDAI, and CRP.
A shorter disease duration, younger age, and a lower BASFI are predictors of a major clinical response to TNF blockers in active AS. Raised CRP and a higher BASDAI may also be valuable predictors. These data need to be confirmed in further studies.
肿瘤坏死因子α阻滞剂已被证明对活动性强直性脊柱炎(AS)患者具有高度疗效。
确定预测AS患者对肿瘤坏死因子阻滞剂临床反应的参数。
活动性AS患者分别参加了在德国进行的两项安慰剂对照随机试验,一项使用英夫利昔单抗(n = 69),另一项使用依那西普(n = 30)。纳入任一试验的患者必须具有高疾病活动度(BASDAI≥4)且尽管使用了非甾体抗炎药,脊柱疼痛评分(数字评定量表0 - 10)仍≥4。主要临床反应定义为使用活性药物治疗12周后初始BASDAI改善50%(BASDAI 50)。进行了逻辑回归似然比检验(单变量和多变量)、学生t检验和卡方检验。
单变量分析显示以下因素是治疗主要反应(BASDAI 50)的预测因素:疾病持续时间较短(p = 0.003);较低的BASFI(p = 0.007);较年轻的年龄(p = 0.009);血沉升高(p = 0.033);C反应蛋白升高(p = 0.035)。在对疾病持续时间、BASFI、血沉和C反应蛋白进行调整后,但年龄未调整,仍存在显著相关性。在对疾病持续时间和BASFI、血沉、C反应蛋白进行调整后,此外,较高的BASDAI与反应显著相关。通过逐步回归建立的最佳多变量模型包含协变量疾病持续时间、BASFI、BASDAI和C反应蛋白。
较短的疾病持续时间、较年轻的年龄和较低的BASFI是活动性AS患者对肿瘤坏死因子阻滞剂主要临床反应的预测因素。C反应蛋白升高和较高的BASDAI也可能是有价值的预测因素。这些数据需要在进一步研究中得到证实。