Department of Rheumatology, Amsterdam University Medical Center, Location VU Medical Center, Amsterdam, The Netherlands
Department of Rheumatology, Amsterdam University Medical Center, Location VU Medical Center, Amsterdam, The Netherlands.
RMD Open. 2020 Apr;6(1). doi: 10.1136/rmdopen-2019-001161.
Acute anterior uveitis (AAU) is the most common extra-articular manifestation in patients with axial spondyloarthritis (axSpA). C-VIEW investigates the impact of the Fc-free TNF inhibitor certolizumab pegol (CZP) on AAU flares in patients with active axSpA at high risk of recurrent AAU.
C-VIEW (NCT03020992) is a 96-week ongoing, multicentre, open-label, phase 4 study. Included patients had an axSpA diagnosis, a history of recurrent AAU (≥2 AAU flares, ≥1 flare in the year prior to study entry), HLA-B27 positivity, active disease, and failure of ≥2 non-steroidal anti-inflammatory drugs. Patients received CZP 400 mg at Weeks 0/2/4, then 200 mg every 2 weeks up to 96 weeks. This 48-week pre-planned interim analysis compares AAU flare incidence in the 48 weeks before and after initiation of CZP treatment, using Poisson regression to account for possible within-patient correlations.
In total, 89 patients were included (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean axSpA disease duration: 8.6 years). During 48 weeks' CZP treatment, 13 (15%) patients experienced 15 AAU flares, representing an 87% reduction in AAU incidence rate (146.6 per 100 patient-years (PY) in the 48 weeks pre-baseline to 18.7 per 100 PY during CZP treatment). Poisson regression analysis showed that the incidence rate of AAU per patient reduced from 1.5 to 0.2 (p<0.001). No new safety signals were identified.
There was a significant reduction in the AAU flare rate during 48 weeks of CZP treatment, indicating that CZP is a suitable treatment option for patients with active axSpA and a history of recurrent AAU.
急性前葡萄膜炎（AAU）是中轴型脊柱关节炎（axSpA）患者最常见的关节外表现。C-VIEW 研究评估了无 Fc 段的 TNF 抑制剂培塞利珠单抗（CZP）对有反复发作性 AAU 风险的活动期 axSpA 患者 AAU 发作的影响。
C-VIEW（NCT03020992）是一项正在进行的、多中心、开放性、4 期研究。纳入患者 axSpA 诊断明确，有反复发作性 AAU（≥2 次 AAU 发作，≥1 次在研究入组前 1 年内发作）史，HLA-B27 阳性，疾病活动，且至少 2 种非甾体抗炎药治疗失败。患者在第 0、2、4 周接受 CZP400mg，之后每 2 周接受 200mg，共 96 周。本项 48 周的预先计划的中期分析采用泊松回归来考虑可能的患者内相关性，比较 CZP 治疗前和治疗后 48 周 AAU 发作的发生率。
共纳入 89 例患者（男性占 63%；放射学/非放射学 axSpA 分别占 85%/15%；axSpA 疾病平均病程：8.6 年）。在 48 周 CZP 治疗期间，13（15%）例患者发生 15 次 AAU 发作，AAU 发生率降低了 87%（48 周基线前的 146.6/100 患者-年降低至 CZP 治疗期间的 18.7/100 患者-年）。泊松回归分析显示，每位患者 AAU 的发生率从 1.5 降至 0.2（p<0.001）。未发现新的安全性信号。
在 48 周 CZP 治疗期间，AAU 发作率显著降低，表明 CZP 是有反复发作性 AAU 病史的活动期 axSpA 患者的一种合适的治疗选择。
