Background

At EU marketing authorisation, safety data for CT-P13 (biosimilar infliximab) were limited, particularly in some indications, and uncommon adverse events (AEs) could not be evaluated among relatively small analysis populations.

Objectives

Our objective was to investigate the overall safety profile and incidence rate of AEs of special interest (AESIs), including serious infections and tuberculosis, in CT-P13-treated patients.

Methods

Data were pooled from six observational studies representing authorised indications of CT-P13 (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, adult and paediatric Crohn’s disease and ulcerative colitis). Patients were analysed by indication and treatment (patients who received CT-P13 or those who switched from reference infliximab to CT-P13 ≤ 6 months prior to enrolment or during the study).

Results

Overall, 4393 patients were included (n = 3677 CT-P13 group; n = 716 switched group); 64.03% of patients had inflammatory bowel disease and 6.31% of patients were antidrug antibody positive. Overall, 32.94% and 9.58% of patients experienced treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs, respectively. Across indications, TEAEs were more frequent with CT-P13 than with the switched group. Infections including tuberculosis were the most frequent serious AESI overall (2.48%) and by treatment group or indication. In total, 14 patients (0.32%) reported active tuberculosis. Overall incidence rates per 100 patient-years (95% confidence interval) were 3.40 (2.788–4.096) for serious infections including tuberculosis and 0.44 (0.238–0.732) for active tuberculosis. Infusion-related reactions were the second most frequent AESI following infection including tuberculosis.

Conclusion

The CT-P13 safety profile appears consistent with previous studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment.

中文翻译：

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观察性队列研究中针对免疫介导的炎性疾病的CT-P13治疗患者的上市后汇总安全性分析。

背景

在获得欧盟市场授权时，CT-P13（生物仿制药英夫利昔单抗）的安全性数据有限，尤其是在某些适应症中，并且无法在相对较小的分析人群中评估罕见的不良事件（AE）。

目标

我们的目标是调查接受CT-P13治疗的患者的特殊安全性（AESI）的总体安全性和发生率，包括严重感染和结核病。

方法

从代表CT-P13（强直性脊柱炎，类风湿性关节炎，银屑病关节炎，斑块状牛皮癣，成年和小儿克罗恩病和溃疡性结肠炎）的授权指征的六项观察研究中收集数据。通过适应症和治疗对患者进行分析（在入组前或研究期间接受CT-P13的患者或从英夫利昔单抗转入CT-P13≤6个月的患者）。

结果

总共纳入了4393名患者（n  = 3677 CT-P13组；n = 716个交换组）；64.03％的患者患有炎症性肠病，而6.31％的患者具有抗药抗体阳性。总体而言，分别有32.94％和9.58％的患者经历了治疗紧急AE（TEAE）和治疗紧急严重AE。在各种适应症中，CT-P13的TEAE发生频率高于开关组。按治疗组或适应症，包括结核病在内的感染是最常见的严重AESI（2.48％）。共有14例患者（0.32％）报告了活动性结核病。对于包括肺结核在内的严重感染，每100个病人年（95％置信区间）的总发生率为3.40（2.788–4.096），而活动性结核病的总发生率为0.44（0.238–0.732）。输液相关的反应是继包括结核病之后的第二大最常见的AESI。

结论

CT-P13的安全性似乎与先前对CT-P13和参考英夫利昔单抗的研究一致，支持了CT-P13治疗的良好风险/获益平衡。