Abstract：
OBJECTIVE: To evaluate the 12-month efficacy and safety profile of adalimumab and etanercept in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA).
UNASSIGNED: Case-series follow-up study.
METHODS: Twenty-eight patients (26 men and 2 women) with active AS (BASDAI > 4) and TSA were treated as follows: 19 patients receiving adalimumab and 9 patients receiving etanercept. Twelve-month data related to the efficacy and safety of these two TNF-alpha inhibitors were evaluated. The primary endpoint was ASAS 20 (the ASsessment in AS International Working Group criteria for 20% improvement) at weeks 12 and 52. Other measures that were evaluated were function (BASFI), disease activity (BASDAI), patient\'s and physician\'s global disease assessment on visual analogue scale (VAS) and C-reactive protein.
RESULTS: In both adalimumab and etanercept groups, there was a significant improvement in all observed variables (baseline compared to weeks 12 and 52). This improvement was sustained for the whole follow-up period. In the adalimumab group, at week 12, ASAS 20 was achieved in 18/19 patients and at week 52 in 17/19 patients. In the etanercept group, at week 12 ASAS 20 was achieved in all patients and at week 52 in 6/9 patients.
CONCLUSIONS: In patients with active AS and TSA, adalimumab and etanercept treatment showed significant improvement in function and disease activity. No serious side effects or adverse effects were observed in our cohort. Key Points • TNF-alpha inhibitors can be effective treatment options for patients with AS and having total spinal ankylosis. • Patients with advanced AS should not be disregarded as good candidates for treatment with biologic disease-modifying antirheumatic drugs.
UNASSIGNED: Case-series follow-up study.
METHODS: Twenty-eight patients (26 men and 2 women) with active AS (BASDAI > 4) and TSA were treated as follows: 19 patients receiving adalimumab and 9 patients receiving etanercept. Twelve-month data related to the efficacy and safety of these two TNF-alpha inhibitors were evaluated. The primary endpoint was ASAS 20 (the ASsessment in AS International Working Group criteria for 20% improvement) at weeks 12 and 52. Other measures that were evaluated were function (BASFI), disease activity (BASDAI), patient\'s and physician\'s global disease assessment on visual analogue scale (VAS) and C-reactive protein.
RESULTS: In both adalimumab and etanercept groups, there was a significant improvement in all observed variables (baseline compared to weeks 12 and 52). This improvement was sustained for the whole follow-up period. In the adalimumab group, at week 12, ASAS 20 was achieved in 18/19 patients and at week 52 in 17/19 patients. In the etanercept group, at week 12 ASAS 20 was achieved in all patients and at week 52 in 6/9 patients.
CONCLUSIONS: In patients with active AS and TSA, adalimumab and etanercept treatment showed significant improvement in function and disease activity. No serious side effects or adverse effects were observed in our cohort. Key Points • TNF-alpha inhibitors can be effective treatment options for patients with AS and having total spinal ankylosis. • Patients with advanced AS should not be disregarded as good candidates for treatment with biologic disease-modifying antirheumatic drugs.
摘要：
目的：评估阿达木单抗和依那西普治疗强直性脊柱炎（AS）和全脊髓强直（TSA）患者的12个月疗效和安全性。
未经评估：病例系列随访研究。
方法：28名患者（26名男性和2名女性）活动性AS（BASDAI>4）和TSA治疗如下：19名患者接受阿达木单抗治疗，9名患者接受依那西普治疗。评估了与这两种TNF-α抑制剂的疗效和安全性相关的12个月数据。主要终点是ASAS20（AS国际工作组标准中20%改善的评估），在第12周和第52周。评估的其他指标是功能(BASFI)，疾病活动（BASDAI），患者和医师对视觉模拟评分(VAS)和C反应蛋白的总体疾病评估。
结果：在阿达木单抗和依那西普组中，所有观察变量均有显著改善(基线与第12周和第52周相比).这种改善在整个随访期间都是持续的。在阿达木单抗组,在第12周时,18/19例患者达到ASAS20,17/19例患者在第52周时达到ASAS20.在依那西普小组中，在第12周时,所有患者达到ASAS20,在第52周时,6/9例患者达到ASAS20.
结论：在活动性AS和TSA患者中，阿达木单抗和依那西普治疗显示功能和疾病活动显著改善.在我们的队列中没有观察到严重的副作用或不良反应。关键点•TNF-α抑制剂可以是AS患者和患有完全脊柱强直的有效治疗选择。•不应忽视晚期AS患者作为生物疾病缓解抗风湿药物治疗的良好候选者。
未经评估：病例系列随访研究。
方法：28名患者（26名男性和2名女性）活动性AS（BASDAI>4）和TSA治疗如下：19名患者接受阿达木单抗治疗，9名患者接受依那西普治疗。评估了与这两种TNF-α抑制剂的疗效和安全性相关的12个月数据。主要终点是ASAS20（AS国际工作组标准中20%改善的评估），在第12周和第52周。评估的其他指标是功能(BASFI)，疾病活动（BASDAI），患者和医师对视觉模拟评分(VAS)和C反应蛋白的总体疾病评估。
结果：在阿达木单抗和依那西普组中，所有观察变量均有显著改善(基线与第12周和第52周相比).这种改善在整个随访期间都是持续的。在阿达木单抗组,在第12周时,18/19例患者达到ASAS20,17/19例患者在第52周时达到ASAS20.在依那西普小组中，在第12周时,所有患者达到ASAS20,在第52周时,6/9例患者达到ASAS20.
结论：在活动性AS和TSA患者中，阿达木单抗和依那西普治疗显示功能和疾病活动显著改善.在我们的队列中没有观察到严重的副作用或不良反应。关键点•TNF-α抑制剂可以是AS患者和患有完全脊柱强直的有效治疗选择。•不应忽视晚期AS患者作为生物疾病缓解抗风湿药物治疗的良好候选者。
