Kilic Konte Elif, Akay Nergis, Gul Umit, Ucak Kubra, Derelioglu Ecenur Izzete, Gurleyik Damla, Aslan Esma, Gunalp Aybuke, Haslak Fatih, Yildiz Mehmet, Adrovic Amra, Sahin Sezgin, Barut Kenan, Kasapcopur Ozgur
Department of Pediatric Rheumatology, Cerrahpasa Medical School, Istanbul University-Cerrahpasa, Istanbul, Turkey.
Expert Opin Drug Saf. 2024 Aug 1:1-9. doi: 10.1080/14740338.2024.2386370.
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.
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.
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 ( < 0.05).
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.
通过记录各种儿科风湿性疾病患者的不良事件，来证明卡那单抗在九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塞拉哈帕萨分校儿科风湿病科进行。分析对象为接受卡那单抗治疗至少六个月的个体。暴露调整后的事件发生率以每100患者日的不良事件计算，并根据卡那单抗累积剂量<35mg/kg、35 - 70mg/kg和>70mg/kg在三组之间进行比较。
189例患者中，卡那单抗的中位暴露时间为2.9（1.5 - 4.1）年，相当于573.4患者年。卡那单抗的中位累积剂量为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例严重不良事件（0.025），其中12例（0.006）导致停药。累积卡那单抗剂量<35mg/kg的患者中，巨噬细胞活化综合征和疾病加重的事件发生率在统计学上更高（<0.05）。
未观察到卡那单抗累积剂量增加导致副作用增加。卡那单抗在适当的适应症和监测下显示出长期安全性。
