Balcı Sibel, Demir İlksen, Serbes Mahir, Doğruel Dilek, Altıntaş Derya Ufuk, Ekinci Rabia Miray Kışla
Department of Pediatric Rheumatology, Cukurova University Faculty of Medicine, Adana, Turkey.
Department of Pediatrics, Cukurova University Faculty of Medicine, Adana, Turkey.
Reumatologia. 2020;58(6):367-374. doi: 10.5114/reum.2020.102001. Epub 2020 Dec 23.
Juvenile idiopathic arthritis is the most common rheumatic disease in childhood. Biologic agents have changed the course of juvenile idiopathic arthritis. However, there are concerns regarding the occurrence of serious adverse events in patients receiving biologic agents. The aim of this study was to evaluate adverse events in children with juvenile idiopathic arthritis receiving biologic agents.
This retrospective study includes juvenile idiopathic arthritis patients receiving biologic agents. Demographic features and adverse events during biologic agents were collected from medical files. Adverse events that either resulted in death, were life-threatening, required inpatient hospitalization, or resulted in persistent or significant disability/incapacity were considered as serious adverse events.
In total, 162 juvenile idiopathic arthritis patients (55.6% female) receiving biologic agents were enrolled: 101 (62.3%) patients treated with etanercept, 27 (16.7) with tocilizumab, 14 (8.6%) with adalimumab, 15 (9.2%) with anti-interleukin 1 agents (13 canakinumab, 2 anakinra), and 5 (3.1%) with infliximab. 75.9% of the patients received concomitantly disease-modifying anti-rheumatic drugs, and 20.4% received disease-modifying anti-rheumatic drugs plus corticosteroid. The mean age at initiation of the biologic agent was 10.5 ±4.3 years. The mean age at the study enrolment was 12.1 ±4.5 years. The mean follow-up duration was 19.7 ±2.1 months. The most frequent adverse event was upper respiratory tract infections (54.3%) followed by urinary tract infections (21%). Anaphylaxis occurred in 3 patients (1.9%): 2 with tocilizumab and one with infliximab. Macrophage activation syndrome occurred in 1 patient (0.6%) receiving tocilizumab. Lung tuberculosis developed in 2 patients (1.2%) receiving canakinumab. The frequency of serious adverse events in total was 6.7%.
While the most frequent adverse events during biologic agents was upper respiratory tract infections, the frequency of serious adverse events was 6.7%; therefore, juvenile idiopathic arthritis patients receiving biologic agents should be carefully evaluated for these adverse events in clinical practice.
幼年特发性关节炎是儿童期最常见的风湿性疾病。生物制剂改变了幼年特发性关节炎的病程。然而，人们担心接受生物制剂治疗的患者会发生严重不良事件。本研究的目的是评估接受生物制剂治疗的幼年特发性关节炎患儿的不良事件。
本回顾性研究纳入接受生物制剂治疗的幼年特发性关节炎患者。从病历中收集人口统计学特征和生物制剂治疗期间的不良事件。导致死亡、危及生命、需要住院治疗或导致持续或严重残疾/无行为能力的不良事件被视为严重不良事件。
共纳入162例接受生物制剂治疗的幼年特发性关节炎患者（女性占55.6%）：101例（62.3%）接受依那西普治疗，27例（16.7%）接受托珠单抗治疗，14例（8.6%）接受阿达木单抗治疗，15例（9.2%）接受抗白细胞介素1制剂治疗（13例卡那单抗，2例阿那白滞素），5例（3.1%）接受英夫利昔单抗治疗。75.9%的患者同时接受改善病情抗风湿药物治疗，20.4%的患者接受改善病情抗风湿药物加皮质类固醇治疗。开始使用生物制剂时的平均年龄为10.5±4.3岁。研究入组时的平均年龄为12.1±4.5岁。平均随访时间为19.7±2.1个月。最常见的不良事件是上呼吸道感染（54.3%），其次是尿路感染（21%）。3例患者（1.9%）发生过敏反应：2例使用托珠单抗，1例使用英夫利昔单抗。1例接受托珠单抗治疗的患者发生巨噬细胞活化综合征（0.6%）。2例接受卡那单抗治疗的患者发生肺结核（1.2%）。严重不良事件的总发生率为6.7%。
虽然生物制剂治疗期间最常见的不良事件是上呼吸道感染，但严重不良事件的发生率为6.7%；因此，在临床实践中，应对接受生物制剂治疗的幼年特发性关节炎患者仔细评估这些不良事件。
