Galletta Francesca, Caminiti Lucia, Lugarà Cecilia, Foti Randazzese Simone, Barraco Paolo, D'Amico Federica, Irrera Pierangela, Crisafulli Giuseppe, Manti Sara
Pediatric Unit, Department of Human Pathology in Adult and Developmental Age "Gaetano Barresi", University of Messina, 98124 Messina, Italy.
Department of Clinical and Experimental Medicine, University of Messina, 98124 Messina, Italy.
J Pers Med. 2023 Jun 29;13(7):1068. doi: 10.3390/jpm13071068.
Insufficient data are available on the long-term "real-life" safety profile of omalizumab in children. This study evaluated the long-term safety of omalizumab in a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). A monocentric, prospective study evaluated the long-term safety of omalizumab in patients aged 6-18 years. Each patient completed the standardized MedDRA questionnaire to identify adverse events (AEs). In total, 23 patients, median age 15 (14-18) years, affected by severe asthma (60.8%) or CSU (39.2%), treated with omalizumab for 2 (1-4) years were enrolled. The most common AEs belong to the system organ class (SOC) of general disorders and administration-site conditions (37.17%). Skin and subcutaneous tissue problems represent the second most frequently reported AEs (24.35%). Central nervous system and musculoskeletal disorders were quite frequent (15.38% and 8.97%, respectively). Other adverse events were tachycardia (5.12%), vertigo and abdominal pain (2.60% and 3.86%, respectively), and dry eye (1.3%). Only one patient reported herpes virus infection during treatment (1.3%). No cases of anaphylaxis, hemopathies, uronephropathies, respiratory, psychiatric, hepatobiliary, or oncological pathologies were reported. Long-term "real-life" treatment with omalizumab in children appears well tolerated. Its safety and efficacy profile makes omalizumab an excellent alternative in severe asthma and CSU in children.
关于奥马珠单抗在儿童中的长期“实际生活”安全性资料不足。本研究评估了奥马珠单抗在患有重度哮喘或慢性自发性荨麻疹（CSU）的儿科队列中的长期安全性。一项单中心前瞻性研究评估了奥马珠单抗在6至18岁患者中的长期安全性。每位患者完成标准化的MedDRA问卷以识别不良事件（AE）。总共纳入了23例患者，中位年龄15（14 - 18）岁，其中60.8%患有重度哮喘，39.2%患有CSU，接受奥马珠单抗治疗2（1 - 4）年。最常见的不良事件属于全身疾病和给药部位情况的系统器官分类（SOC）（37.17%）。皮肤和皮下组织问题是报告的第二常见不良事件（24.35%）。中枢神经系统和肌肉骨骼疾病相当常见（分别为15.38%和8.97%）。其他不良事件包括心动过速（5.12%）、眩晕和腹痛（分别为2.60%和3.86%）以及干眼（1.3%）。治疗期间仅有1例患者报告疱疹病毒感染（1.3%）。未报告过敏反应、血液系统疾病、泌尿系统疾病、呼吸系统、精神系统、肝胆系统或肿瘤疾病病例。儿童长期“实际生活”中使用奥马珠单抗似乎耐受性良好。其安全性和有效性使其成为儿童重度哮喘和CSU的极佳替代药物。
