Efficacy and predictors of rapid response to omalizumab therapy in patients with seasonal allergic rhinitis: a cohort study.

D. Fomina, O.U. Mukhina, E. Bobrikova, M. Lebedkina, A. Chernov, M. Lysenko
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Abstract

BACKGROUND: The availability of anti-IgE therapy for allergic rhinitis (AR) has actualized the need to develop variants of this treatment according to predictors of rapid response and the tactics of treatment initiation. AIMS: To study efficacy and predictors of response to omalizumab in patients with seasonal AR (SAR). MATERIALS AND METHODS: Patients with moderate or severe SAR with insufficient effectiveness of traditional treatment for at least 3 months in previous pollen season or with no effect of therapy in current season were included. The decision to prescribe omalizumab was made based on the visual analog scale (VAS) in the previous or current season. Dosage and frequency of administration (every 2 or 4 weeks) were determined according to the table values due to the instructions. The patients were observed for 2 months. At follow-up visits (1 and 2 months later), AR symptom control was assessed using VAS and TNSS. Therapy was considered effective when the VAS remained 30 or decreased 30 after 4 and 8 weeks from the start of therapy, depending on the initiation period. RESULTS: The study enrolled 30 patients with AR history of 14 years, sensitization to 2 or more groups of allergens in 19 (63,3%) cases, bronchial asthma (BA) in 18 (60%). In 6 patients (20%) omalizumab was initiated before the pollen season, in 24 patients (80%) during the season. After 4 weeks, control of AR manifestations was achieved in 23 (77%) patients, and by week 8, 100% of patients with AR had fully responded to therapy. In patients, the severity of AR symptoms on the VAS/ TNSS scales decreased by 2.7 and 4.7 times, respectively, by 4 weeks of follow-up. The proportion of patients with a slow response by week 4 of therapy was 23%. BMI (lower in the "slow" response group) and history of BA (2.6 times longer in the "slow" responders) were associated with the achievement of this outcome. No adverse events were recorded. CONCLUSIONS: Omalizumab in patients with SAR allows to achieve control of manifestations of the disease already after 4 weeks of therapy with its maintenance in follow-up. Predictors of rapid response have been revealed, but their clinical significance requires further study.
奥玛珠单抗治疗对季节性变应性鼻炎患者快速反应的疗效和预测因素:一项队列研究
背景:抗ige治疗变应性鼻炎(AR)的可用性已经实现了根据快速反应的预测因素和治疗开始策略开发这种治疗的变体的需要。目的:研究奥玛珠单抗在季节性AR (SAR)患者中的疗效和反应预测因素。材料与方法:纳入以往花粉季节传统治疗效果不足至少3个月或当前花粉季节治疗无效果的中重度SAR患者。处方omalizumab的决定是基于之前或当前季节的视觉模拟量表(VAS)。根据说明书按表值确定给药剂量和给药频率(每2周或每4周)。观察2个月。随访(1个月和2个月后),采用VAS和TNSS评估AR症状控制情况。当VAS在治疗开始后4周和8周保持30或下降30时,视起始时间而定,认为治疗有效。结果:该研究纳入了30例AR病史为14年的患者,对2组或2组以上过敏原致敏的19例(63.3%),支气管哮喘(BA) 18例(60%)。6例患者(20%)在花粉季节前开始使用omalizumab, 24例患者(80%)在花粉季节开始使用omalizumab。4周后,23例(77%)患者的AR表现得到控制,到第8周,100%的AR患者对治疗完全有反应。在患者中,VAS/ TNSS量表上的AR症状严重程度在随访4周时分别下降了2.7倍和4.7倍。治疗第4周时反应缓慢的患者比例为23%。BMI(在“慢”反应组较低)和BA史(在“慢”反应组较长2.6倍)与实现这一结果有关。无不良事件记录。结论:在SAR患者中使用Omalizumab可以在治疗4周后实现疾病表现的控制,并在随访中维持。快速反应的预测因子已被发现,但其临床意义有待进一步研究。
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