Abstract：
UNASSIGNED: To demonstrate the long-term safety profile of canakinumab over a nine-year period by documenting adverse events in patients with various pediatric rheumatic diseases.
UNASSIGNED: This retrospective observational study was conducted at the Pediatric Rheumatology Department of Istanbul University Cerrahpasa between 2015 and 2023. The analysis concerned individuals who had been administered canakinumab treatment for at least six months. The exposure-adjusted event rates were calculated as adverse events per 100 patient days and were compared among three groups based on the cumulative canakinumab dose of <35 mg/kg, 35-70 mg/kg, and >70 mg/kg.
UNASSIGNED: Among 189 patients, the median exposure time to canakinumab was 2.9 (1.5-4.1) years, corresponding to 573.4 patient years. The median cumulative dose of canakinumab was 2205 (1312-3600) mg. The most common adverse event was upper respiratory tract infection (0.76), followed by urinary tract infection (0.02), pneumonia (0.009), latent tuberculosis (0.009) and lymphadenitis (0.004). A total of 55 serious adverse events (0.025) were reported, 12 (0.006) of which led to drug discontinuation. The event rate of macrophage activation syndrome and disease exacerbation was statistically higher in patients receiving <35 mg/kg cumulative canakinumab dose (p < 0.05).
UNASSIGNED: An increase in side effect was not observed with the increasing cumulative doses of canakinumab. Canakinumab demonstrated long-term safety with appropriate indication and monitoring.
UNASSIGNED: This retrospective observational study was conducted at the Pediatric Rheumatology Department of Istanbul University Cerrahpasa between 2015 and 2023. The analysis concerned individuals who had been administered canakinumab treatment for at least six months. The exposure-adjusted event rates were calculated as adverse events per 100 patient days and were compared among three groups based on the cumulative canakinumab dose of <35 mg/kg, 35-70 mg/kg, and >70 mg/kg.
UNASSIGNED: Among 189 patients, the median exposure time to canakinumab was 2.9 (1.5-4.1) years, corresponding to 573.4 patient years. The median cumulative dose of canakinumab was 2205 (1312-3600) mg. The most common adverse event was upper respiratory tract infection (0.76), followed by urinary tract infection (0.02), pneumonia (0.009), latent tuberculosis (0.009) and lymphadenitis (0.004). A total of 55 serious adverse events (0.025) were reported, 12 (0.006) of which led to drug discontinuation. The event rate of macrophage activation syndrome and disease exacerbation was statistically higher in patients receiving <35 mg/kg cumulative canakinumab dose (p < 0.05).
UNASSIGNED: An increase in side effect was not observed with the increasing cumulative doses of canakinumab. Canakinumab demonstrated long-term safety with appropriate indication and monitoring.
摘要：
■通过记录各种儿科风湿性疾病患者的不良事件，证明canakinumab在9年期间的长期安全性。
■这项回顾性观察性研究于2015年至2023年在伊斯坦布尔大学Cerrahpasa儿科风湿病学系进行。该分析涉及已接受canakinumab治疗至少六个月的个体。暴露校正事件率计算为每100例患者天的不良事件，并基于<35mg/kg的canakinumab累积剂量在三组之间进行比较。35-70mg/kg,和>70mg/kg。
■在189名患者中，canakinumab的中位暴露时间为2.9（1.5-4.1）年，对应于573.4患者年。canakinumab的中位累积剂量为2205(1312-3600)mg。最常见的不良事件是上呼吸道感染（0.76），其次是尿路感染（0.02），肺炎（0.009），潜伏性结核（0.009）和淋巴结炎（0.004）。共报告了55起严重不良事件（0.025起），12（0.006）其中导致药物停药。在接受<35mg/kgcanakinumab累积剂量的患者中,巨噬细胞活化综合征和疾病恶化的事件发生率在统计学上较高(p<0.05)。
■随着加纳单抗的累积剂量的增加,没有观察到副作用的增加。Canakinumab在适当的适应症和监测下证明了长期安全性。
■这项回顾性观察性研究于2015年至2023年在伊斯坦布尔大学Cerrahpasa儿科风湿病学系进行。该分析涉及已接受canakinumab治疗至少六个月的个体。暴露校正事件率计算为每100例患者天的不良事件，并基于<35mg/kg的canakinumab累积剂量在三组之间进行比较。35-70mg/kg,和>70mg/kg。
■在189名患者中，canakinumab的中位暴露时间为2.9（1.5-4.1）年，对应于573.4患者年。canakinumab的中位累积剂量为2205(1312-3600)mg。最常见的不良事件是上呼吸道感染（0.76），其次是尿路感染（0.02），肺炎（0.009），潜伏性结核（0.009）和淋巴结炎（0.004）。共报告了55起严重不良事件（0.025起），12（0.006）其中导致药物停药。在接受<35mg/kgcanakinumab累积剂量的患者中,巨噬细胞活化综合征和疾病恶化的事件发生率在统计学上较高(p<0.05)。
■随着加纳单抗的累积剂量的增加,没有观察到副作用的增加。Canakinumab在适当的适应症和监测下证明了长期安全性。
