Rudwaleit Martin, Olivieri Ignazio, Boki Kyriaki A, Griep Eduard N, Järvinen Pentti, Wong Robert L, Kron Martina, Kary Sonja, Kupper Hartmut
Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Berlin, Germany.
Rheumatology (Oxford). 2009 May;48(5):551-7. doi: 10.1093/rheumatology/kep022. Epub 2009 Mar 1.
To evaluate the effectiveness and safety of adalimumab in treating patients with AS and advanced structural damage.
Patients with active AS [Bath AS Disease Activity Index (BASDAI) > or =4] received 40 mg of adalimumab every other week plus their standard anti-rheumatic therapies in this 12-week, open-label study. Investigators documented the presence or absence of advanced ankylosis based on previous radiographs. Stages IV (from 50 to <80% involvement in more than two spinal segments) and V (> or =80% spinal involvement, including bamboo spine) disease were considered as advanced AS. Effectiveness parameters included Assessment of SpondyloArthritis international Society (ASAS) criteria, BASDAI response and achievement of optimal sleep. Adverse events were reported throughout therapy and at a 70-day follow-up.
The analysis population included 897 patients whose AS was not advanced (i.e. Stages I-III), 31 with Stage IV disease and 41 with Stage V disease. At Week 12, ASAS40/BASDAI 50 responses were achieved by 54%/57% of patients with AS Stages I-III, 48%/58% with AS Stage IV and 54%/66% with AS Stage V, respectively. ASAS partial remission rates were 30, 26 and 7% for patients with Stages I-III, IV and V disease, respectively. Serious infections occurred in three (<1%) patients with AS Stages I-III and in one (1%) patient with AS Stage V.
After 12 weeks of adalimumab therapy, patients with advanced but active AS, including those with structural damage of > or =80% of the vertebrae, achieved improvements in signs and symptoms similar to those attained by patients whose AS was not advanced.
评估阿达木单抗治疗强直性脊柱炎（AS）及晚期结构损伤患者的有效性和安全性。
在这项为期12周的开放标签研究中，活动性AS患者[巴斯强直性脊柱炎疾病活动指数（BASDAI）≥4]每隔一周接受40mg阿达木单抗治疗，并联合其标准抗风湿治疗。研究人员根据既往X线片记录是否存在晚期关节强硬。IV期（两个以上脊柱节段受累达50%至<80%）和V期（脊柱受累≥80%，包括竹节样脊柱）疾病被视为晚期AS。有效性参数包括国际脊柱关节炎协会（ASAS）标准、BASDAI反应及达到最佳睡眠情况。在整个治疗过程及70天随访期内报告不良事件。
分析人群包括897例非晚期AS患者（即I - III期）、31例IV期疾病患者和41例V期疾病患者。在第12周时，I - III期AS患者中分别有54%/57%达到ASAS40/BASDAI 50反应，IV期AS患者为48%/58%，V期AS患者为54%/66%。I - III期、IV期和V期疾病患者的ASAS部分缓解率分别为30%、26%和7%。I - III期AS患者中有3例（<1%）发生严重感染，V期AS患者中有1例（1%）发生严重感染。
阿达木单抗治疗12周后，晚期但仍处于活动期的AS患者，包括椎体结构损伤≥80%的患者，其体征和症状的改善情况与非晚期AS患者相似。
