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一项针对 802 例炎症性关节炎患者的全国性非医学性从原研英夫利昔单抗转换为生物类似药 CT-P13 的研究:DANBIO 注册研究的 1 年临床结果。

A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry.

机构信息

The DANBIO registry and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.

Department of Rheumatology, Gentofte and Herlev University Hospital, Gentofte, Denmark.

出版信息

Ann Rheum Dis. 2017 Aug;76(8):1426-1431. doi: 10.1136/annrheumdis-2016-210742. Epub 2017 May 4.

Abstract

OBJECTIVES

According to guidelines, a nationwide non-medical switch from originator (INX, Remicade) to biosimilar infliximab (Remsima, CT-P13) was conducted in Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). We investigated disease activity before/after switching and retention rates in the DANBIO registry.

METHODS

Disease activities 3 months before and after switch and changes over time were calculated. Flare was defined as change in 28 Joint Disease Activity Score (∆DAS28) ≥1.2 (RA/PsA) or Ankylosing Spondylitis Disease Activity Score (∆ASDAS) ≥1.3 (AxSpA). Crude and adjusted retention rates were compared with a historic cohort of INX-treated patients.

RESULTS

Eight hundred and two patients switched (403 RA/120 PsA/279 AxSpA; 51% women, age (median (IQR): 55 (44-66)) years). Follow-up was 413 (339-442) days. Prior INX treatment duration was 6.8 (4.3-9.5) years. Disease activities were similar 3 months before/after switch. Crude 1-year CT-P13 retention rate (84.1 (95% CI 81.3 to 86.5)) was similar to the historic IFX cohort (86.2 (95% CI 84.0 to 88.0), p=0.22). The adjusted absolute retention rates were 83.4 (95% CI 80.8 to 86.2) and 86.8% (95% CI 84.8 to 88.8), respectively (p=0.03). In total 132 patients withdrew (lack of effect: 71/132=54%, adverse events: 37/132=28%). Patients with previous INX treatment duration >5 years had longer CT-P13 retention.

CONCLUSION

In 802 arthritis patients treated with INX for median >6 years, a nationwide non-medical switch to CT-P13 had no negative impact on disease activity. Adjusted 1-year CT-P13 retention rate was slightly lower than for INX in a historic cohort.

摘要

目的

根据指南,丹麦的类风湿关节炎(RA)、银屑病关节炎(PsA)和中轴型脊柱关节炎(AxSpA)患者进行了一次全国范围内非医学的从原研药(INX,Remicade)到生物类似药英夫利昔单抗(Remsima,CT-P13)的转换。我们在 DANBIO 登记处调查了转换前后的疾病活动度和保留率。

方法

计算转换前/后 3 个月的疾病活动度和随时间的变化。Flare 定义为 28 关节疾病活动度评分(∆DAS28)变化≥1.2(RA/PsA)或强直性脊柱炎疾病活动度评分(∆ASDAS)变化≥1.3(AxSpA)。与 INX 治疗患者的历史队列进行了粗保留率和调整保留率的比较。

结果

802 例患者(403 例 RA/120 例 PsA/279 例 AxSpA;51%为女性,年龄(中位数(IQR):55(44-66)岁)进行了转换。随访时间为 413(339-442)天。之前 INX 治疗时间为 6.8(4.3-9.5)年。转换前后 3 个月的疾病活动度相似。CT-P13 的 1 年粗保留率(84.1(95%CI81.3-86.5))与历史 IFX 队列相似(86.2(95%CI84.0-88.0),p=0.22)。调整后的绝对保留率分别为 83.4(95%CI80.8-86.2)和 86.8%(95%CI84.8-88.8)(p=0.03)。共有 132 例患者停药(无疗效:71/132=54%,不良反应:37/132=28%)。INX 治疗时间>5 年的患者 CT-P13 保留时间更长。

结论

在接受 INX 中位治疗时间>6 年的 802 例关节炎患者中,全国范围内非医学的从 INX 到 CT-P13 的转换对疾病活动度没有负面影响。调整后的 1 年 CT-P13 保留率略低于历史队列中的 INX。

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