Rudwaleit Martin, Claudepierre Pascal, Wordsworth Paul, Cortina Eduardo Loza, Sieper Joachim, Kron Martina, Carcereri-De-Prati Roberto, Kupper Hartmut, Kary Sonja
Charité-University Medicine Berlin, Campus Benjamin Franklin Hospital, Medical Department I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany.
J Rheumatol. 2009 Apr;36(4):801-8. doi: 10.3899/jrheum.081048. Epub 2009 Feb 27.
We evaluated the effectiveness and safety of adalimumab in a large cohort of patients with active ankylosing spondylitis (AS) and identified clinical predictors of good clinical response.
Patients with active AS [Bath AS Disease Activity Index (BASDAI)>or=4] received adalimumab 40 mg every other week in addition to their standard antirheumatic therapies in a multinational 12-week, open-label study. We used 3 definitions of good clinical response: 50% improvement in the BASDAI (BASDAI=50), 40% improvement in the ASsessments of SpondyloArthritis International Society criteria (ASAS40), or ASAS partial remission. Response predictors were determined by logistic regression with backward elimination (selection level 5%).
Of 1250 patients, 1159 (92.7%) completed 12 weeks of adalimumab treatment. At Week 12, 57.2% of patients achieved BASDAI 50, 53.7% achieved ASAS40, and 27.7% achieved ASAS partial remission. Important predictors of good clinical response (BASDAI 50, ASAS40, and partial remission) were younger age (p<0.001), and greater C-reactive protein (CRP) concentration (p<or=0.001), HLA-B27 positivity (p<or=0.01), and tumor necrosis factor (TNF) antagonist naivety (p<0.001).
Adalimumab was effective in this large cohort of patients with AS, with more than half of patients achieving a BASDAI 50 or ASAS40 response and more than a quarter of patients reaching partial remission at Week 12.Younger age, greater CRP concentrations, HLA-B27 positivity, and TNF antagonist naivety were strongly associated with BASDAI 50, ASAS40, and partial remission responses. ClinicalTrials.gov identifier: NCT00478660.
我们评估了阿达木单抗在一大群活动性强直性脊柱炎（AS）患者中的有效性和安全性，并确定了良好临床反应的临床预测因素。
在一项为期12周的跨国开放标签研究中，活动性AS患者[巴斯强直性脊柱炎疾病活动指数（BASDAI）≥4]在接受标准抗风湿治疗的基础上，每隔一周接受40mg阿达木单抗治疗。我们使用了3种良好临床反应的定义：BASDAI改善50%（BASDAI=50）、国际脊柱关节炎学会评估标准（ASAS40）改善40%或ASAS部分缓解。通过逐步回归法（选择水平5%）的逻辑回归确定反应预测因素。
1250例患者中，1159例（92.7%）完成了12周的阿达木单抗治疗。在第12周时，57.2%的患者达到BASDAI 50，53.7%的患者达到ASAS40，27.7%的患者达到ASAS部分缓解。良好临床反应（BASDAI 50、ASAS40和部分缓解）的重要预测因素为年龄较小（p<0.001）、C反应蛋白（CRP）浓度较高（p≤0.001）、HLA-B27阳性（p≤0.01）和未使用过肿瘤坏死因子（TNF）拮抗剂（p<0.001）。
阿达木单抗在这一大群AS患者中有效，超过一半的患者在第12周时达到BASDAI 50或ASAS40反应，超过四分之一的患者达到部分缓解。年龄较小、CRP浓度较高、HLA-B27阳性和未使用过TNF拮抗剂与BASDAI 50、ASAS40和部分缓解反应密切相关。ClinicalTrials.gov标识符：NCT00478660。
