Real-world use of omalizumab in patients with chronic idiopathic/spontaneous urticaria in the United States
Real-world use of omalizumab in patients with chronic idiopathic/spontaneous urticaria in the United States
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DOI：
10.2500/aap.2018.39.4132
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发表时间：
2018-05-01
影响因子：
2.8
通讯作者：
Bernstein, Jonathan A.
中科院分区：
文献类型：
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作者：
Eghrari-Sabet, Jacqueline;Sher, Ellen;Bernstein, Jonathan A.
背景资料：奥马珠单抗于2014年3月在美国获批用于治疗慢性特发性荨麻疹（CIU）/慢性自发性荨麻疹（CSU）。目的：本研究旨在描述奥马珠单抗在美国一个大型CIU/CSU患者队列中的真实使用情况。CIU/CSU患者（年龄≥ 12岁）开始omalizumab治疗在保险索赔数据库（2013年1月1日至2016年7月31日）中确定了索引前和索引后数据>= 12个月的（索引日期）。治疗模式，包括omalizumab的给药方案和连续使用（无间隙>= 60天），在12个月postindex随访period.Results：共1546例患者（平均+/-标准差[SD]年龄，44 +/- 14.5岁，73.1%的妇女）进行了描述。大多数患者（84.5%）开始接受奥马珠单抗300 mg剂量; 90%维持初始剂量，7.5%增加剂量，4.6%降低剂量。平均+/- SD奥马珠单抗治疗持续时间为9.1 +/- 3.8个月，平均+/- SD奥马珠单抗给药次数为8.3 +/- 4.8次，平均+/- SD给药频率为44 +/- 29天。连续接受奥马珠单抗治疗6、9和12个月的患者比例分别为67.3%、54.8%和47.4%。在停用奥马珠单抗≥ 3个月（39.8%）的患者中，21%在平均+/- SD 4.4 +/- 1.3个月后重新开始治疗。使用其他CIU/CSU相关药物的患者比例在索引前至索引后下降（94.8%至81.1%），观察到口服皮质类固醇的降幅最大（75.7%至49.9%）。结论：在这项大型真实世界研究中，大多数CIU/CSU患者开始使用300 mg奥马珠单抗剂量，平均治疗9个月，未上调或下调剂量。大多数患者连续接受奥马珠单抗治疗≥ 6个月，1/4停止治疗的患者重新开始治疗。此外，与基线水平相比，奥马珠单抗开始治疗后，其他CIU/CSU相关药物的使用减少，口服皮质类固醇的减少最明显。
Background: Omalizumab was approved for the treatment of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in the United States in March 2014.Objective: This study sought to describe real-world omalizumab use, in the United States, in a large cohort of patients with CIU/CSU.Methods: Patients with CIU/CSU (ages >= 12 years) initiated on omalizumab (index date) with >= 12 months of pre-and postindex data were identified in the an insurance claims data base (January 1, 2013, to July 31, 2016). Treatment patterns, including the dosing regimen and continuous use of omalizumab (no gaps for >= 60 days), were described during the 12-month postindex follow-up period.Results: A total of 1546 patients (mean +/- standard deviation [SD] ages, 44 +/- 14.5 years; 73.1% women) were identified. Most of the patients (84.5%) were initiated on omalizumab 300-mg dose; 90% maintained the initial dose, 7.5% had a dose increase, and 4.6% had a dose decrease. The mean +/- SD omalizumab treatment duration was 9.1 +/- 3.8 months, the mean +/- SD number of omalizumab administrations was 8.3 +/- 4.8, and the mean +/- SD administration frequency was 44 +/- 29 days. A proportion of the patients continuously treated with omalizumab for 6, 9, and 12 months was 67.3, 54.8, and 47.4%, respectively. Among the patients who discontinued omalizumab for >= 3 months (39.8%), 21% restarted the treatment after a mean +/- SD of 4.4 +/- 1.3 months. The proportion of patients who used other CIU/CSU-related medications decreased pre-to postindex (94.8 to 81.1%), with the highest decrease observed in oral corticosteroids (75.7 to 49.9%).Conclusion: In this large real-world study, the majority of the patients with CIU/CSU were initiated on a 300-mg omalizumab dose and treated without titration up or down for 9 months on average. Most of the patients were continuously treated with omalizumab for >= 6 months, and one-fourth of the patients who discontinued treatment resumed it. Moreover, compared with baseline levels, the use of other CIU/CSU-related medications was lower after omalizumab initiation, with the most prominent decrease observed in oral corticosteroids.