Rheumazentrum Ruhrgebiet Herne, Ruhr-University, Bochum.
Hannover Medical School, Hannover Medical School, Hanover, Germany.
Rheumatology (Oxford). 2021 Jan 5;60(1):113-124. doi: 10.1093/rheumatology/keaa181.
The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA.
CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ≥1 dose CZP were followed up for adverse events, and those with baseline and ≥1 post-baseline BASDAI assessment were included in effectiveness analyses.
A total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ≥1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was -2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was -2.9 (2.2; n = 301) and -2.8 (2.4; n = 137), respectively (P <0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced ≥1 serious adverse events.
Improvements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.
在临床试验环境中，已证实无 Fc 段且聚乙二醇化的抗 TNF 药物 certolizumab pegol（CZP）对轴性脊柱关节炎（axSpA）有效且安全。我们报告了 CZP 在包括放射学（r-）和非放射学（nr-）axSpA 在内的欧洲临床实践中的有效性和安全性。
CIMAX（NCT02354105）是一项欧洲非干预性多中心前瞻性研究，观察了 CZP 在真实世界 axSpA 队列中治疗 12 个月的反应和安全性。主要结局是从基线到第 52 周 BASDAI 的变化，其他结局与有效性和安全性相关。对接受至少 1 剂 CZP 的患者进行不良反应随访，对基线和至少 1 次基线后 BASDAI 评估的患者进行有效性分析。
共 101 个研究点的 672 名患者（r-axSpA：469 名；nr-axSpA：201 名；未确诊：2 名）接受了至少 1 剂 CZP，其中 564 名（r-axSpA：384 名；nr-axSpA：179 名；未确诊：1 名）被纳入有效性分析。总体 axSpA 人群以及 r-axSpA 和 nr-axSpA 亚群的基线平均 BASDAI 为 6.1。在第 52 周，BASDAI 的平均（标准差）变化为-2.9（2.3；n=439）；r-axSpA 和 nr-axSpA 分别为-2.9（2.2；n=301）和-2.8（2.4；n=137）（均<0.0001）。在其他 axSpA 疾病指标中也观察到了相似的改善。总体而言，37.9%（255/672）的患者出现不良反应，1.8%（12/672）的患者出现≥1 例严重不良反应。
在真实世界临床实践中，接受 CZP 治疗一年后 axSpA 的体征和症状得到改善，与之前的随机临床试验相似，没有新的安全性问题。
