Abstract：
To evaluate the safety of canakinumab using real-world data in patients with systemic juvenile idiopathic arthritis (sJIA) and autoinflammatory diseases (AID).
This was a cross-sectional observational, multicenter study. Patients diagnosed with AID and sJIA treated with canakinumab were included in the study. The participating 13 centers retrospectively collected their patients\' data.
A total of 335 patients were involved in the study. Among these patients, 280 were in the AID group and 55 were in the sJIA group. Canakinumab was administered at a median dose of 3 (2.5-4) mg/kg. The median total exposure time to canakinumab was 1.9 (0.8-3.2) years, corresponding to 759.5 patient-years. Seven hundred and seventy-nine total adverse events (AE) were identified. The total incidence of AE, and serious adverse events (SAE) throughout the study period was 1.02 per patient-years. The upper respiratory tract infection rate was 0.7 per patient-years, while the other infection rate was 0.13 per patient-years. While no death was observed in any patient, SAE were observed in 8 patients. Interstitial lung disease, anaphylaxis, or anaphylactoid reactions were not observed in any patient.
Real-life data from a large cohort of patients suggests that canakinumab is as safe as claimed in clinical trials.
This was a cross-sectional observational, multicenter study. Patients diagnosed with AID and sJIA treated with canakinumab were included in the study. The participating 13 centers retrospectively collected their patients\' data.
A total of 335 patients were involved in the study. Among these patients, 280 were in the AID group and 55 were in the sJIA group. Canakinumab was administered at a median dose of 3 (2.5-4) mg/kg. The median total exposure time to canakinumab was 1.9 (0.8-3.2) years, corresponding to 759.5 patient-years. Seven hundred and seventy-nine total adverse events (AE) were identified. The total incidence of AE, and serious adverse events (SAE) throughout the study period was 1.02 per patient-years. The upper respiratory tract infection rate was 0.7 per patient-years, while the other infection rate was 0.13 per patient-years. While no death was observed in any patient, SAE were observed in 8 patients. Interstitial lung disease, anaphylaxis, or anaphylactoid reactions were not observed in any patient.
Real-life data from a large cohort of patients suggests that canakinumab is as safe as claimed in clinical trials.
摘要：
■使用真实世界数据评估canakinumab在系统性幼年特发性关节炎（sJIA）和自身炎性疾病（AID）患者中的安全性。
■这是一个横截面观测，多中心研究。该研究包括诊断为AID和sJIA的患者，这些患者接受了canakinumab治疗。参与的13个中心回顾性收集了他们的患者数据。
■共有335名患者参与了这项研究。在这些患者中,AID组280人，sJIA组55人。以3(2.5-4)mg/kg的中值剂量施用Canakinumab。canakinumab的中位总暴露时间为1.9（0.8-3.2）年，对应于759.5患者年。共发现779起不良事件(AE)。AE的总发生率，在整个研究期间,严重不良事件(SAE)为1.02/患者-年.上呼吸道感染率为每病人年0.7例,而其他感染率为每患者年0.13。虽然没有观察到任何患者的死亡，在8例患者中观察到SAE。间质性肺病,过敏反应，在任何患者中均未观察到类过敏反应。
■来自大量患者的真实数据表明，canakinumab与临床试验中声称的一样安全。
■这是一个横截面观测，多中心研究。该研究包括诊断为AID和sJIA的患者，这些患者接受了canakinumab治疗。参与的13个中心回顾性收集了他们的患者数据。
■共有335名患者参与了这项研究。在这些患者中,AID组280人，sJIA组55人。以3(2.5-4)mg/kg的中值剂量施用Canakinumab。canakinumab的中位总暴露时间为1.9（0.8-3.2）年，对应于759.5患者年。共发现779起不良事件(AE)。AE的总发生率，在整个研究期间,严重不良事件(SAE)为1.02/患者-年.上呼吸道感染率为每病人年0.7例,而其他感染率为每患者年0.13。虽然没有观察到任何患者的死亡，在8例患者中观察到SAE。间质性肺病,过敏反应，在任何患者中均未观察到类过敏反应。
■来自大量患者的真实数据表明，canakinumab与临床试验中声称的一样安全。
