强直性脊柱炎活动指数（ASDAS)在日常诊疗种评估生物制剂治疗患者的应用－来自葡萄牙登记系统风湿病患者

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Performance of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in Patients Under Biological Therapies in Daily Practice – Results From the Portuguese Register Reuma.Pt

 

Sofia Ramiro ¹, Pedro Machado², Raquel Roque³, Helena Santos⁴, Joaquim Polido-Pereira⁵, Daniela Peixoto⁶, Cátia Duarte⁷, Fernando Pimentel-Santos⁸, Cândida Silva⁴, J. E. Fonseca⁵, Filipa Teixeira⁶, Andrea Marques⁷, Filipe Araújo⁸, Jaime C. Branco⁸, José Pereira Da-Silva⁷, José Costa⁶, Jose A. Pereira Da Silva⁹, Luis Cunha Miranda⁴, J. Canas da Silva³, Helena Canhão⁵, A.M. Van Tubergen¹⁰, Desirée van der Heijde¹¹, Robert Landewé¹² and MJ Santos³, ¹Hospital Garcia de Orta, Almada, Portugal and Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands, ²Hospitais da Universidade de Coimbra, Coimbra, Portugal and Leiden University Medical Center, Leiden, Netherlands, ³Hospital Garcia de Orta, Almada, Portugal, ⁴Instituto Português de Reumatologia, Lisboa, Portugal, ⁵Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa and Rheumatology Department, Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria, Lisboa, Portugal, ⁶Centro Hospitalar do Alto Minho, Hospital de Ponte de Lima, Ponte de Lima, Portugal, ⁷Hospitais da Universidade de Coimbra, Coimbra, Portugal, ⁸Centro Hospitalar de Lisboa Ocidental, Hospital Egas Moniz, Lisboa, Portugal, ⁹Centro Hospitalar de Lisboa Norte, Hospital de Santa Maria, Lisboa, Portugal, ¹⁰Maastricht University Medical Center, Maastricht, Netherlands, ¹¹Leiden University Medical Center, Leiden, Netherlands, ¹²Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands

 

Presentation Number: 507

 

Background/Purpose: The Ankylosing Spondylitis Disease Activity Score (ASDAS) is the new index to measure disease activity in Ankylosing Spondylitis (AS). Our aim was to address validity and discriminatory aspects of the ASDAS, as well as to analyse the performance of the ASDAS disease activity states and response criteria in the setting of an observational cohort of patients with AS starting biological therapies.

Method: Patients with AS under biological therapy and followed in the Portuguese register of rheumatic diseases (Reuma.pt) were included in this analysis. Reuma.pt is used as an electronic medical record and assessments are performed by rheumatologists. All patients with baseline data were used for cross-sectional analysis (n = 264). For the longitudinal analyses, follow-up visits at 12 and 24 weeks and with an ASDAS-CRP available were required (n = 109). Pearson coefficients were calculated to establish the correlation between disease activity measurements at baseline. Discrimination between patients with low versus high disease activity according to the patient’s global assessment (PGA) was analysed as the standardised mean difference (SMD). The percentage of patients within each ASDAS disease activity state at each time point and the percentage of patients achieving ASDAS improvement criteria at 12 and 24 weeks were determined and the latter were compared with other response measures.

Results: The ASDAS showed a good correlation with the PGA (0.66), and simultaneously a good correlation with acute phase reactants (CPR 0.61; ESR 0.52). The ASDAS was discriminatory, with similar SMDs to the ones from BASDAI. Results were consistent for the whole population as well as in subgroups of baseline CRP (at a cutoff of 5g/l) and disease duration (at a cutoff of 5 years). ASDAS disease activity in states showed a clinically meaningful shift from high to low over time (Table 1). The same pattern was found in the subgroups of CRP and disease duration. The ASDAS improvement criteria identified more patients with clinically meaningful improvement than the classical criteria did (Table 2), and the same results were also found in the subgroups of CRP and disease duration.

Conclusion: The ASDAS is a discriminatory instrument for disease activity in the setting of usual clinical practice.

 

 

强直性脊柱炎活动指数（ASDAS)在日常诊疗种评估生物制剂治疗患者的应用－来自葡萄牙登记系统风湿病患者的数据

Sofia Ramiro , et al. ACR 2011. Present No:506

背景/目的:强直性脊柱炎疾病活动指数 (ASDAS)是衡量强直性脊柱炎(AS)疾病活动度的新指标。本研究目的是评价其有效性和分辨力,以及对开始生物制剂治疗的AS患者观察人群疾病活动状态和疗效反应的评价作用。

方法:本研究纳入了葡萄牙风湿病注册系统(Reuma.pt)中生物制剂治疗的AS患者。采用其电子医学记录并由风湿病医生作相应评估。对所有患者的基线数据进行横断面分析(n = 264)。纵向分析中,要求作第12周和第24周随访并有ASDAS-CRP (n = 109)。用Pearson相关系数计算基线水平疾病活动测量值之间的相关性。根据病人总体评估（PGA）区别活动度低和高的患者，分析两组间的差异并用标准均数差（SMD）表示。计算不同时间点不同ASDAS活动度范围的患者比例和第12周和24周达到ASDAS改善标准的患者比例，并将后者与其他疗效指标相比较。

结果:ASDAS与PGA (0.66)以及急性相反应物(CPR 0.61;ESR 0.52)均有较好的相关性。ASDAS的分辨率良好，与BASDAI的SMD相似。总的患者群与基线水平不同（如CRP以5g/l为界限和病程5年为界）的各亚群结果一致 。某个阶段的ASDAS疾病活动度随时间延长呈现由高到低具临床意义的变化 (表1)。同样的模式也可见于CRP亚组和病程不同亚组中。相比经典的标准，ASDAS改善标准鉴别出更多有临床意义的改善患者(表2), 同样上述结果可见于不同CRP和病程亚组。

结论: ASDAS是日常临床实践中判别疾病活动度的有效工具。

Table 1 - Longitudinal evolution of ASDAS disease activity states

Time point	N	ASDAS < 1.3 N (%)	1.3 ≤ ASDAS < 2.1 N (%)	2.1 ≤ ASDAS < 3.5 N (%)	ASDAS > 3.5 N (%)
Baseline	109	0 (0%)	3 (2.8%)	46 (42.2%)	60 (55.0%)
12 weeks	109	33 (30.3%)	25 (22.9%	42 (38.5%)	9 (8.3%)
24 weeks	109	30 (27.5%)	29 (2 .6%)	40 (36.7%)	10 (9.2%)

 

Table 2 - Percentage of patients achieving different improvement criteria

	12 weeks (n = 91)	24 weeks (n = 91)
Δ ASDAS ≥ 1.1	57 (62.6%)	55 (60.4%)
Δ ASDAS ≥ 2.0	36 (39.6%)	34 (37.4%)
Δ BASDAI ≥ 2.0	46 (50.6%	46 (50.6%)
BASDAI50	40 (44.0%)	37 (40.7%)
ASAS20	51 (56.0%)	51 (56.0%)
ASAS40	42 (46.2%)	44 (48.4%)