University Hospital Charité, Berlin, Germany.
Arthritis Rheumatol. 2015 Mar;67(3):668-77. doi: 10.1002/art.38973.
Previous reports of the RAPID-axSpA trial (NCT01087762) described the efficacy and safety of certolizumab pegol (CZP) over 24 weeks in patients with axial spondyloarthritis (SpA), including ankylosing spondylitis (AS) and nonradiographic axial SpA. We report efficacy and safety data up to week 96 of the study.
The RAPID-axSpA trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Outcome variables included Assessment of SpondyloArthritis international Society criteria for 20% and 40% improvement in disease activity (ASAS20/40), ASAS partial remission responses (analyzed by nonresponder imputation), AS Disease Activity Score (ASDAS), ASDAS inactive disease, ASDAS major improvement, Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Bath AS Metrology Index (BASMI) linear score (analyzed by the last observation carried forward method). Safety data were collected for patients treated with ≥1 dose of CZP.
Of the 325 patients who were randomized, 218 received CZP from week 0. Of these, 93% completed week 24, 88% completed week 48, and 80% completed week 96. Improvements in ASAS responses were maintained to week 96 (for ASAS20, 67.4%, 72.0%, and 62.8% at weeks 24, 48, and 96, respectively), as well as improvements in ASDAS, BASDAI (mean score 3.3, 3.1, and 3.0 at weeks 24, 48, and 96, respectively), BASFI, and BASMI linear score. Comparable improvements were observed with both dosing regimens (200 mg every 2 weeks or 400 mg every 4 weeks) and in patients with AS and those with nonradiographic axial SpA. In the safety set, adverse events occurred in 279 patients (88.6%) and serious adverse events in 41 (13.0%). No deaths or malignancies were reported.
Clinical improvements to week 24 in both CZP dosing regimens were sustained to week 96. Similar sustained improvements were observed in AS and nonradiographic axial SpA subpopulations. The safety profile was consistent with previous reports from RAPID-axSpA, with no new safety signals observed with longer exposure.
先前 RAPID-axSpA 试验（NCT01087762）的报告描述了培塞利珠单抗（CZP）在 24 周内治疗轴性脊柱关节炎（axSpA）患者（包括强直性脊柱炎（AS）和非放射学 axSpA）的疗效和安全性。我们报告了研究中至第 96 周的疗效和安全性数据。
RAPID-axSpA 试验是一项双盲、安慰剂对照试验，至第 24 周，第 48 周开始剂量盲法，第 204 周开放标签。疗效变量包括评估强直性脊柱炎国际学会（ASAS）20%和 40%疾病活动度改善标准、ASAS 部分缓解反应（采用非应答者插补法分析）、AS 疾病活动评分（ASDAS）、AS 疾病无活动状态、ASDAS 主要改善、 Bath AS 疾病活动指数（BASDAI）、Bath AS 功能指数（BASFI）和 Bath AS 计量学指数（BASMI）线性评分（采用最后观察值结转法分析）。对接受 CZP 治疗≥1 剂量的患者进行安全性数据收集。
325 名随机患者中，218 名患者从第 0 周开始接受 CZP 治疗。其中，93%完成第 24 周，88%完成第 48 周，80%完成第 96 周。至第 96 周，ASAS 反应的改善仍保持（ASAS20，第 24、48 和 96 周时分别为 67.4%、72.0%和 62.8%），ASDAS、BASDAI（第 24、48 和 96 周时平均评分分别为 3.3、3.1 和 3.0）、BASFI 和 BASMI 线性评分也有所改善。两种剂量方案（每 2 周 200mg 或每 4 周 400mg）和 AS 患者和非放射学 axSpA 患者均观察到类似的改善。在安全性组中，279 例患者（88.6%）出现不良事件，41 例（13.0%）出现严重不良事件。无死亡或恶性肿瘤报告。
两种 CZP 剂量方案在第 24 周的临床改善持续至第 96 周。在 AS 和非放射学 axSpA 亚组中观察到类似的持续改善。安全性特征与 RAPID-axSpA 的先前报告一致，在更长的暴露时间内未观察到新的安全性信号。
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