van der Horst-Bruinsma Irene E, van Bentum Rianne E, Verbraak Frank D, Deodhar Atul, Rath Thomas, Hoepken Bengt, Irvin-Sellers Oscar, Thomas Karen, Bauer Lars, Rudwaleit Martin
Department of Rheumatology, Amsterdam University Medical Center, Location VU Medical Center, De Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands.
Department of Rheumatology, Amsterdam University Medical Centers, Location VU Medical Centre, Amsterdam, The Netherlands.
Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211003803. doi: 10.1177/1759720X211003803. eCollection 2021.
Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU.
C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks' CZP 2 years pre-baseline.
Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12-0.28), < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified.
CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU.
NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992.
急性前葡萄膜炎（AAU）影响高达40%的中轴型脊柱关节炎（axSpA）患者，若治疗不当有导致永久性视力缺陷的风险。我们报告了C-VIEW研究的2年结果，这是第一项前瞻性研究培塞利珠单抗（CZP）对复发AAU高风险的活动性axSpA患者的AAU疗效的研究。
C-VIEW（NCT03020992）是一项为期104周（96周加8周安全性随访）的开放标签、多中心研究。符合条件的患者患有活动性axSpA、人类白细胞抗原-B27（HLA-B27）阳性且有复发AAU病史（总共⩾2次AAU发作；基线前一年至少1次）。患者在第0、2和4周接受400mg CZP治疗，然后每2周接受200mg治疗至第96周。主要疗效终点是在基线前2年的96周CZP治疗期间的AAU发作事件率。
115名入组患者中，89名开始使用CZP（男性：63%；放射学/非放射学axSpA：85%/15%；平均病程：9.1年）；83名完成了第96周的治疗。在基线前的CZP治疗期间，AAU发作事件率显著降低了82%[率比（95%置信区间）：0.18（0.12 - 0.28），<0.001]。基线前分别有100%和59.6%的患者经历了⩾1次和⩾2次AAU发作，而治疗期间这一比例分别为20.2%和11.2%。年龄、性别和axSpA人群亚组分析与主要分析结果一致。axSpA疾病活动度有显著改善，未发现新的安全信号。
CZP治疗显著降低了有AAU病史的axSpA患者的AAU发作事件率，表明CZP是复发AAU风险患者的合适治疗选择。
ClinicalTrials.gov：NCT03020992，网址：https://clinicaltrials.gov/ct2/show/NCT03020992 。
