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抗 TNF 治疗反应的预测因子:英国风湿病学会生物制剂登记处的结果。

Predictors of response to anti-TNF therapy in ankylosing spondylitis: results from the British Society for Rheumatology Biologics Register.

机构信息

University of Manchester, Manchester Academic Health Sciences Centre, Manchester M13 9PT, UK.

出版信息

Rheumatology (Oxford). 2010 Mar;49(3):563-70. doi: 10.1093/rheumatology/kep422. Epub 2009 Dec 23.

Abstract

OBJECTIVE

Few data exist on the use of anti-TNF drugs for AS during routine clinical use in the UK. This report describes an improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) after 6 months of therapy in 261 patients enrolled in a national prospective observational register.

METHODS

The British Society for Rheumatology Biologics Register (BSRBR) recruited patients starting anti-TNF therapy for AS between 2002 and 2006. Multivariable linear regression models were used to estimate the predictors of absolute improvement in BASDAI and BASFI at 6 months. Covariates included age, gender, disease duration, baseline BASDAI and BASFI, presence of raised inflammatory markers (defined as twice the upper limit of normal) and DMARD therapy.

RESULTS

The cohort was young (median age 43 years) and 82% were males. Median baseline BASDAI was 7.6 and BASFI 7.9. At 6 months, the mean improvements in BASDAI and BASFI were 3.6 and 2.6 U, respectively; 52% reached a BASDAI50. Patients with raised inflammatory markers at the start of therapy had a 0.9-U (95% CI 0.2, 1.5) better improvement in BASDAI compared with those without. Lesser responses were seen in those with higher baseline BASFI scores. Women had a 1.1-U (95% CI 0.3, 2.0) greater improvement in BASFI at 6 months, as did those who were receiving concurrent DMARD therapy [0.9 U (95% CI 0.2, 1.7)].

CONCLUSIONS

The majority of patients receiving anti-TNF therapy for AS during routine care demonstrated an improvement in disease activity. Raised inflammatory markers at the start of therapy predicted a greater improvement in BASDAI, identifying a group of patients who may be more responsive to anti-TNF therapies, although the results were not confined to this group.

摘要

目的

在英国常规临床实践中,关于抗 TNF 药物治疗 AS 的数据很少。本报告描述了在 2002 年至 2006 年期间开始接受抗 TNF 治疗的 261 例患者的英国风湿病学会生物制剂登记处(BSRBR)注册数据中,6 个月治疗后 Bath 强直性脊柱炎疾病活动指数(BASDAI)和 Bath 强直性脊柱炎功能指数(BASFI)的改善情况。

方法

BSRBR 招募了接受抗 TNF 治疗的 AS 患者。使用多变量线性回归模型来估计 6 个月时 BASDAI 和 BASFI 绝对改善的预测因素。协变量包括年龄、性别、疾病持续时间、基线 BASDAI 和 BASFI、是否存在升高的炎症标志物(定义为正常值上限的两倍)和 DMARD 治疗。

结果

该队列的年龄较轻(中位数年龄 43 岁),82%为男性。基线中位数 BASDAI 为 7.6,BASFI 为 7.9。6 个月时,BASDAI 和 BASFI 的平均改善分别为 3.6 和 2.6 U,52%达到 BASDAI50。与基线无升高炎症标志物的患者相比,开始治疗时存在升高炎症标志物的患者的 BASDAI 改善程度要好 0.9 U(95%CI 0.2,1.5)。基线 BASFI 评分较高的患者反应较小。女性在 6 个月时 BASFI 的改善程度更大(1.1 U,95%CI 0.3,2.0),同时接受 DMARD 治疗的患者也有改善(0.9 U,95%CI 0.2,1.7)。

结论

在常规护理中接受抗 TNF 治疗的大多数 AS 患者的疾病活动度均有改善。开始治疗时存在升高的炎症标志物可预测 BASDAI 更大的改善,确定了一组对抗 TNF 治疗可能更敏感的患者,尽管结果不限于该组。

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