a Center for Rheumatic Diseases , University of Medicine and Pharmacy , Bucharest , Romania.
b Revmatologie , Revmatologie MU Dr. Klara Sirova, sro , Ostrava , Czech Republic.
Curr Med Res Opin. 2018 Oct;34(10):1763-1769. doi: 10.1080/03007995.2018.1441144. Epub 2018 Apr 16.
To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS).
This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations. Effectiveness was assessed using the 4-item Disease Activity Score 28 with C-reactive protein (DAS28-CRP) for RA patients, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. Safety was assessed by withdrawals and adverse events (AEs).
A total of 129 patients (RA: 67; AS: 62) were included in the effectiveness analysis. CT-P13 treatment significantly improved DAS28-CRP scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with RA and BASDAI scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with AS. CRP levels were significantly reduced at 12 and 24 weeks (p = .0001 vs baseline for both timepoints). Among 713 infusions, 34 AEs were reported (4.8% of infusions), of which 11 were considered related to CT-P13 treatment. Two of seven serious AEs were considered possibly (hepatocellular injury) or definitely (dyspnoea due to allergic infusion reaction) treatment-related. Eight patients discontinued CT-P13 due to AEs and four patients were withdrawn due to therapeutic failure.
CT-P13 was effective and safe in a real-life setting in patients with active RA or AS.
评估英夫利昔单抗生物类似药 CT-P13 在真实环境中用于治疗活动期类风湿关节炎（RA）或强直性脊柱炎（AS）成年患者的疗效和安全性。
这是一项多中心、非干预性、观察性研究，在保加利亚、捷克共和国和罗马尼亚进行。共纳入 151 例严重活动期 RA（n=81）或 AS（n=70）患者，根据当前的医学建议，使用 CT-P13 治疗 24 周。RA 患者采用 4 项疾病活动评分 28 与 C 反应蛋白（DAS28-CRP），AS 患者采用 Bath 强直性脊柱炎疾病活动指数（BASDAI）评估疗效。通过停药和不良事件（AE）评估安全性。
共纳入 129 例患者（RA：67 例；AS：62 例）进行疗效分析。CT-P13 治疗可显著改善 RA 患者的 DAS28-CRP 评分（12 周和 24 周，p<0.0001，均与基线相比）和 AS 患者的 BASDAI 评分（12 周和 24 周，p<0.0001，均与基线相比）。CRP 水平在 12 周和 24 周时显著降低（p<0.0001，均与基线相比）。在 713 次输注中，报告了 34 例 AEs（输注的 4.8%），其中 11 例被认为与 CT-P13 治疗有关。7 例严重 AEs 中有 2 例被认为可能（肝细胞损伤）或肯定（过敏输注反应引起的呼吸困难）与治疗相关。8 例患者因 AEs 停用 CT-P13，4 例患者因治疗失败停用 CT-P13。
CT-P13 在真实环境中用于治疗活动期 RA 或 AS 患者是有效且安全的。
