Jahan Rowshne, Huq Ziaul
Department of Respiratory Medicine, Evercare Hospital, Dhaka, 1229, Bangladesh.
Curr Res Pharmacol Drug Discov. 2025 Apr 5;8:100218. doi: 10.1016/j.crphar.2025.100218. eCollection 2025.
Severe allergic asthma (SAA) requires high-dose inhaled corticosteroids and additional medications. It poses a substantial health and financial burden. Omalizumab, an antibody that targets IgE, has improved symptoms and quality of life in severe allergic asthma (SAA) patients. Its impact in Bangladeshi patients is unknown, and this study aimed to evaluate its effectiveness in improving lung function in severe allergic asthma (SAA) patients.
This single-centre, real-world study aimed to assess omalizumab's effectiveness in 131 Bangladeshi patients with SAA. Information regarding demographics, BMI, and IgE levels, were collected from patients >12 years with poorly controlled SAA before and 3 months after omalizumab treatment. Pulmonary function tests (PFTs), including Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 s (FEV1 %), FEV1/FVC (%), and Fractional Exhaled Nitric Oxide (FeNO), were performed according to established guidelines. A structured questionnaire was used for data collection. Ethical measures were taken in accordance with the current Declaration of Helsinki.
The mean age of study population was 42.7 ± 16.15 (SD) years with majority being female (67.9 %). The mean BMI and IgE level was 28 ± 5.37 kg/m and 594.3 ± 679.9 IU/mL respectively. The mean baseline FVC, FEV and FEV/FVC ratio was 63.5 % ± 19.2, 61.3 % ± 21.8 and 80.4 % ± 12.6 respectively. The mean post-omalizumab FVC, FEV and FEV/FVC ratio was 72.5 % ± 25.6, 68.3 % ± 28.2 and 79.1 % ± 13.8 respectively. The FeNO reading revealed that number of patients with <25 ppb reading increased post omalizumab treatment (70.2 % vs 84 %).FEV expressed was significantly higher in patients post-omalizumab treatment than at the baseline (p = 0.019) and percentage of patients with FEV below the predicted 50 % was higher at baseline compared to after omalizumab treatment (31.3 % vs 23.7 %). Similarly, the FVC was significantly higher post-omalizumab treatment compared to baseline (p = 0.001). The FEV/FVC ratio was not significantly different post omalizumab treatment (p = 0.758).
Our study finding have suggested that omalizumab as add on therapy achieved an adequate asthma control in patients with severe allergic asthma.
重度过敏性哮喘（SAA）需要高剂量吸入性糖皮质激素及其他药物治疗。它带来了巨大的健康和经济负担。奥马珠单抗是一种靶向IgE的抗体，已改善了重度过敏性哮喘（SAA）患者的症状和生活质量。其对孟加拉国患者的影响尚不清楚，本研究旨在评估其在改善重度过敏性哮喘（SAA）患者肺功能方面的有效性。
这项单中心、真实世界研究旨在评估奥马珠单抗对131例孟加拉国重度过敏性哮喘患者的有效性。收集年龄大于12岁、SAA控制不佳患者在奥马珠单抗治疗前及治疗3个月后的人口统计学、体重指数（BMI）和IgE水平信息。根据既定指南进行肺功能测试（PFTs），包括用力肺活量（FVC）、第1秒用力呼气量（FEV1%）、FEV1/FVC（%）和呼出一氧化氮分数（FeNO）。使用结构化问卷进行数据收集。按照现行《赫尔辛基宣言》采取了伦理措施。
研究人群的平均年龄为42.7±16.15（标准差）岁，大多数为女性（67.9%）。平均BMI和IgE水平分别为28±5.37kg/m²和594.3±679.9IU/mL。奥马珠单抗治疗前FVC、FEV1和FEV1/FVC比值的平均值分别为63.5%±19.2、61.3%±21.8和80.4%±12.6。奥马珠单抗治疗后FVC、FEV1和FEV1/FVC比值的平均值分别为72.5%±25.6、68.3%±28.2和79.1%±13.8。FeNO读数显示，奥马珠单抗治疗后FeNO读数<25ppb的患者数量增加（70.2%对84%）。奥马珠单抗治疗后患者的FEV1表达明显高于基线水平（p=0.019），且基线时FEV1低于预测值50%的患者百分比高于奥马珠单抗治疗后（31.3%对23.7%）。同样，奥马珠单抗治疗后的FVC明显高于基线（p=0.001）。奥马珠单抗治疗后FEV1/FVC比值无显著差异（p=0.758）。
我们的研究结果表明，奥马珠单抗作为附加疗法可使重度过敏性哮喘患者的哮喘得到充分控制。
