Real-world clinical utility (effectiveness) of omalizumab as add-on therapy in patient with difficult-to-treat severe allergic asthma

Q2 Agricultural and Biological Sciences

Current Research in Pharmacology and Drug Discovery Pub Date : 2025-01-01 DOI:10.1016/j.crphar.2025.100218

Rowshne Jahan, Ziaul Huq

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Abstract

Background

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.

Methods

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.

Results

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/m² and 594.3 ± 679.9 IU/mL respectively. The mean baseline FVC, FEV₁ and FEV₁/FVC ratio was 63.5 % ± 19.2, 61.3 % ± 21.8 and 80.4 % ± 12.6 respectively. The mean post-omalizumab FVC, FEV₁ and FEV₁/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 %).FEV₁ expressed was significantly higher in patients post-omalizumab treatment than at the baseline (p = 0.019) and percentage of patients with FEV₁ 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 FEV₁/FVC ratio was not significantly different post omalizumab treatment (p = 0.758).

Conclusion

Our study finding have suggested that omalizumab as add on therapy achieved an adequate asthma control in patients with severe allergic asthma.

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奥马珠单抗作为难以治疗的严重过敏性哮喘患者的附加疗法的实际临床效用（有效性

背景：严重过敏性哮喘（SAA）需要大剂量吸入皮质类固醇和其他药物治疗。它造成了巨大的健康和财政负担。Omalizumab是一种靶向IgE的抗体，可改善严重过敏性哮喘（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，本研究旨在评估其改善严重过敏性哮喘（SAA）患者肺功能的有效性。本研究旨在评估omalizumab在131例孟加拉国SAA患者中的有效性。在奥玛单抗治疗前和治疗后3个月，收集了12年SAA控制不佳的患者的人口统计学、BMI和IgE水平信息。肺功能测试（PFTs），包括用力肺活量（FVC）、1s用力呼气量（FEV1 %）、FEV1/FVC（%）和呼气一氧化氮分数（FeNO），均按照既定指南进行。数据收集采用结构化问卷。按照目前的《赫尔辛基宣言》采取了道德措施。结果研究人群平均年龄为42.7±16.15 （SD）岁，女性居多（67.9%）。BMI平均值为28±5.37 kg/m2， IgE平均值为594.3±679.9 IU/mL。平均基线FVC、FEV1和FEV1/FVC比值分别为63.5%±19.2、61.3%±21.8和80.4%±12.6。平均FVC、FEV1和FEV1/FVC比值分别为72.5%±25.6、68.3%±28.2和79.1%±13.8。FeNO读数显示，奥玛珠单抗治疗后，读数为<； 25ppb的患者数量增加（70.2%对84%）。omalizumab治疗后患者FEV1的表达明显高于基线（p = 0.019）， FEV1低于预测的50%的患者百分比在基线时高于omalizumab治疗后（31.3%对23.7%）。同样，与基线相比，奥玛珠单抗治疗后FVC显著升高（p = 0.001）。奥玛珠单抗治疗后FEV1/FVC比值无显著差异（p = 0.758）。结论我们的研究结果表明，奥玛珠单抗加药治疗对严重过敏性哮喘患者达到了充分的哮喘控制。

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