Ancochea J, Chivato T, Casan P, Picado C, Herráez L, Casafont J
Hospital de la Princesa, Madrid, Spain.
Hospital Central de la Defensa, Madrid, Spain.
Allergol Immunopathol (Madr). 2014 Mar-Apr;42(2):102-8. doi: 10.1016/j.aller.2012.10.010. Epub 2012 Dec 23.
Omalizumab is indicated in patients with severe allergic asthma not controlled by high-dose inhaled glucocorticoids and long-acting beta-agonists. Few data are available on the profile of patients treated with this drug in routine clinical practice in Spain.
To describe the profile of patients with severe allergic asthma treated with omalizumab and the course of the disease after a period of treatment.
Retrospective, multicentre study, recording the data on patients of either sex and ≥12 years with uncontrolled severe allergic asthma, previously treated with omalizumab. Data were evaluated in relation to pulmonary function, symptoms, quality of life, and concomitant anti-asthma treatment before the prescription of omalizumab and at the time of the study visit.
214 patients were evaluable (mean age=48.2±17.7 years; mean age at the time of diagnosis=26.6±16.5 years). 90.7% had experienced exacerbations the year before receiving omalizumab, and the mean total IgE level was 273±205.4IU/ml. The mean monthly dose was 380.5±185.4mg. Compared with the baseline situation, differences were observed after treatment with omalizumab in mean FEV1 (62.7±15.9% vs. 70.8±18.7%), in the proportion of patients requiring oral corticosteroids (47.7% vs. 14.0%), and in the ACQ and AQLQ scores. 32.7% of the patients received doses not recommended by the Summary of Product Characteristics (SPC).
Profile of asthmatic patients treated with omalizumab predominantly corresponds to uncontrolled severe asthma cases, in accordance with SPC's indications. The results of the study suggest a favourable clinical course similar to that observed in other studies.
奥马珠单抗适用于使用高剂量吸入糖皮质激素和长效β受体激动剂仍无法控制的重度过敏性哮喘患者。在西班牙的常规临床实践中,关于使用这种药物治疗的患者情况的数据很少。
描述接受奥马珠单抗治疗的重度过敏性哮喘患者的情况以及治疗一段时间后的疾病进程。
回顾性多中心研究,记录年龄≥12岁、患有未控制的重度过敏性哮喘且此前接受过奥马珠单抗治疗的男女患者的数据。在奥马珠单抗处方前和研究访视时,对与肺功能、症状、生活质量及同时使用的抗哮喘治疗相关的数据进行评估。
214例患者可进行评估(平均年龄=48.2±17.7岁;诊断时平均年龄=26.6±16.5岁)。90.7%的患者在接受奥马珠单抗治疗前一年有过病情加重,平均总IgE水平为273±205.4IU/ml。平均每月剂量为380.5±185.4mg。与基线情况相比,奥马珠单抗治疗后,平均第一秒用力呼气容积(FEV1)(62.7±15.9%对70.8±18.7%)、需要口服糖皮质激素的患者比例(47.7%对14.0%)以及哮喘控制问卷(ACQ)和哮喘生活质量问卷(AQLQ)评分均有差异。32.7%的患者接受了产品特性摘要(SPC)未推荐的剂量。
接受奥马珠单抗治疗的哮喘患者情况主要与SPC适应症中未控制的重度哮喘病例相符。研究结果表明临床病程良好,与其他研究中观察到的情况相似。