Rottem Menachem
Division of Allergy Asthma and Clinical Immunology, Emek Medical Center, Afula, Israel.
J Asthma. 2012 Feb;49(1):78-82. doi: 10.3109/02770903.2011.637598. Epub 2011 Dec 7.
Approved by the FDA in 2003, omalizumab is the first recombinant humanized monoclonal anti-immunoglobulin E antibody developed for the treatment of allergic asthma. Due to the heterogeneity of asthma symptoms, investigation of the efficacy of omalizumab in patients outside controlled trials is particularly important. The purpose of the current study was to evaluate the efficacy of omalizumab as an add-on treatment for allergic asthma in a real-life setting in Israel.
This was a retrospective study based on patient records and computerized database for drug dispensing, emergency room visits, and hospital admissions.
The sample comprised 33 individuals (18 men, 15 women; mean age 50.0 ± 12.2, range 25-79) who were treated with omalizumab for severe allergic asthma for a duration of at least 16 weeks. After the initiation of omalizumab therapy, the number of patients who used oral or injected corticosteroids decreased (p < .003, .03, respectively), as did the median dosage of oral corticosteroids (p < .02). Visits to the emergency room decreased from an incidence of 0.526 visits per person-year to an incidence of 0.246 per person-year (p < .05). No adverse reactions to omalizumab were observed.
Omalizumab as an add-on therapy reduced the use of corticosteroids and improved the control of asthma, as evidenced by reduced asthma-related emergency room visits. This study supports both controlled and uncontrolled studies that have demonstrated the efficacy and safety of omalizumab, and particularly those that demonstrated effectiveness among severe asthma patients. "Real-life" studies are important to identify patients who will most benefit from omalizumab therapy.
奥马珠单抗于2003年获美国食品药品监督管理局(FDA)批准,是首个研发用于治疗过敏性哮喘的重组人源化单克隆抗免疫球蛋白E抗体。由于哮喘症状的异质性,在对照试验之外研究奥马珠单抗在患者中的疗效尤为重要。本研究的目的是评估奥马珠单抗作为附加疗法在以色列现实环境中治疗过敏性哮喘的疗效。
这是一项基于患者记录以及药物配给、急诊就诊和住院计算机数据库的回顾性研究。
样本包括33名个体(18名男性,15名女性;平均年龄50.0±12.2岁,范围25 - 79岁),他们接受奥马珠单抗治疗重度过敏性哮喘至少16周。开始奥马珠单抗治疗后,使用口服或注射皮质类固醇的患者数量减少(分别为p <.003和p <.03),口服皮质类固醇的中位剂量也减少(p <.02)。急诊就诊率从每人每年0.526次降至每人每年0.246次(p <.05)。未观察到对奥马珠单抗的不良反应。
奥马珠单抗作为附加疗法减少了皮质类固醇的使用,并改善了哮喘控制,哮喘相关急诊就诊减少证明了这一点。本研究支持已证明奥马珠单抗疗效和安全性的对照和非对照研究,特别是那些证明在重度哮喘患者中有效的研究。“现实生活”研究对于确定最能从奥马珠单抗治疗中获益的患者很重要。