Ma Tingting, Wang Hongtian, Wang Xueyan
Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing Key Laboratory of Bio-Characteristic Profiling for Evaluation of Rational Drug Use, Beijing 100038, People's Republic of China.
Department of Otolaryngology Head and Neck Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, People's Republic of China.
J Asthma Allergy. 2021 Jan 22;14:59-66. doi: 10.2147/JAA.S288952. eCollection 2021.
Omalizumab has been proven effective and safety in treating seasonal allergic rhinitis (SAR) by several randomized clinical trials in many countries. However, there is lack of clinical reports of Chinese patients with SAR treated by omalizumab.
In the present real-world-designed study, we aimed to investigate the effectiveness of omalizumab in treating patients with SAR.
SAR patients administered omalizumab in various dosages were recruited, and follow-up was done. Their quality of life (QOL) and symptoms were assessed by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Total Nasal Symptoms Score (TNSS), Asthma Control Test (ACT), and clinical outcomes were compared between post- and pre-treatment conditions.
Sixty SAR patients received omalizumab therapy in the study (mean age 35.47±17.02 years, 35 females). Omalizumab treatment significantly improved the quality of life (change in RQLQ overall score: -2.08±1.01, paired -test p<0.001) and nasal symptoms (change in TNSS: -7.33±2.50, paired -test p<0.001) of SAR patients. In 21 patients with co-existing asthma, the ACT score significantly increased from 16.10 to 22.57 on average (paired -test p<0.001), indicating better-controlled asthma. Using a threshold of ≥1 point improvement in RQLQ overall score, 83.3% of patients responded to omalizumab. The responder group had a higher baseline RQLQ score and TNSS (p<0.05), but both responders and non-responders had comparable scores after treatment. Multiple linear regression analysis identified the baseline RQLQ overall score as a predictor of change in the RQLQ score in omalizumab-treated SAR.
Omalizumab is effective and safe in SAR treatment in a real-world setting.
在许多国家进行的多项随机临床试验已证明奥马珠单抗治疗季节性变应性鼻炎（SAR）有效且安全。然而，缺乏中国SAR患者接受奥马珠单抗治疗的临床报告。
在本项真实世界设计的研究中，我们旨在调查奥马珠单抗治疗SAR患者的有效性。
招募接受不同剂量奥马珠单抗治疗的SAR患者，并进行随访。通过鼻结膜炎生活质量问卷（RQLQ）、总鼻症状评分（TNSS）、哮喘控制测试（ACT）评估他们的生活质量（QOL）和症状，并比较治疗前后的临床结局。
60例SAR患者在本研究中接受了奥马珠单抗治疗（平均年龄35.47±17.02岁，女性35例）。奥马珠单抗治疗显著改善了SAR患者的生活质量（RQLQ总分变化：-2.08±1.01，配对t检验p<0.001）和鼻症状（TNSS变化：-7.33±2.50，配对t检验p<0.001）。在21例合并哮喘的患者中，ACT评分平均从16.10显著提高到22.57（配对t检验p<0.001），表明哮喘得到更好控制。以RQLQ总分改善≥1分为阈值，83.3%的患者对奥马珠单抗有反应。有反应组的基线RQLQ评分和TNSS较高（p<0.05），但治疗后有反应者和无反应者的评分相当。多元线性回归分析确定基线RQLQ总分是奥马珠单抗治疗的SAR患者RQLQ评分变化的预测因素。
在真实世界环境中，奥马珠单抗治疗SAR有效且安全。
