Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro, Bari, Italy.
Scientific Directorate, IRCCS Burlo Garofolo, Trieste, Italy.
Ann Allergy Asthma Immunol. 2018 Mar;120(3):318-323. doi: 10.1016/j.anai.2017.12.007.
Omalizumab therapy is effective and safe in patients with chronic spontaneous urticaria (CSU) resistant to nonsedating histamine (H) antihistamines (nsAHs).
To evaluate the efficacy and safety of omalizumab in elderly (aged ≥65 years) patients with nonsedating H-antihistamine-refractory CSU in a real-life setting.
Patients with nonsedating H-antihistamine-refractory CSU (n = 322) treated with omalizumab administered every 4 weeks in doses of 300 mg for 24 weeks were divided into 2 groups according to age at omalizumab treatment onset: 15 to 64 years and 65 years or older. Treatment response was assessed using a 7-day urticaria activity score (UAS7). Adverse effects of omalizumab therapy were recorded.
Among patients, 32 (9.9%) were 65 years or older. At baseline, CSU characteristics were generally similar among the groups, although the presence of angioedema was statistically significantly lower in patients younger than 65 years. Any differences in weekly itch severity score, hive score, and UAS7 between the 2 age groups were not significant at weeks 4, 12, and 24, with the exception of the hive score at 24 weeks and the UAS7 at week 24. No significant between-group differences were seen in the proportion of patients with a UAS7 of 6 or lower and with a UAS7 score of 0 at weeks 4, 12, 24, and 40. The proportion of patients with at least one adverse event reported as suspected to be caused by study drug was 10% in the younger group vs 6.3% in the older group (P = .53).
Our study found that omalizumab is a well-tolerated and effective therapy for elderly patients with nonsedating H-antihistamine-refractory CSU.
奥马珠单抗治疗对非镇静组胺（H）抗组胺药（nsAHs）耐药的慢性自发性荨麻疹（CSU）患者有效且安全。
在真实环境中评估奥马珠单抗在非镇静 H 抗组胺药难治性 CSU 的老年（≥65 岁）患者中的疗效和安全性。
将 322 名接受奥马珠单抗治疗的非镇静 H 抗组胺药难治性 CSU 患者（n=322）分为两组，根据奥马珠单抗治疗开始时的年龄：15-64 岁和 65 岁或以上。使用 7 天荨麻疹活动评分（UAS7）评估治疗反应。记录奥马珠单抗治疗的不良反应。
在患者中，32 名（9.9%）年龄在 65 岁或以上。在基线时，两组患者的 CSU 特征通常相似，尽管 65 岁以下患者血管性水肿的发生率明显较低。在第 4、12 和 24 周时，两组间每周瘙痒严重程度评分、荨麻疹评分和 UAS7 差异无统计学意义，除了第 24 周的荨麻疹评分和第 24 周的 UAS7。在第 4、12、24 和 40 周时，UAS7 为 6 或更低和 UAS7 为 0 的患者比例在两组间无显著差异。报告至少有一次疑似与研究药物相关的不良事件的患者比例，年轻组为 10%，老年组为 6.3%（P=0.53）。
我们的研究发现，奥马珠单抗是一种耐受良好且有效的治疗非镇静 H 抗组胺药难治性 CSU 的老年患者的方法。
