Omalizumab in the severe exacerbations of seasonal allergic rhinitis

K. Pavlova, D. S. Kulichenko, O. Kurbacheva, M. E. Dyneva, N. Ilina
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Abstract

Background: according to the Federal Clinical Guidelines (FCG), patients with severe persistent allergic rhinitis (AR) and/or severe exacerbation and with the ineffectiveness of the 3rd line pharmacotherapy (antihistamines, leukotriene receptor antagonists, nasal corticosteroids) are recommended to consider the appointment of the omalizumab, but there aren`t practical recommendations on the regimens and duration of the omalizumab therapy in the severe exacerbation of seasonal AR. Aim: omalizumab additional therapy in patients with severe exacerbation of AR during the pollen season to assess the efficacy and to determine the optimal regimen and duration of treatment. Materials and methods: this is an open observational uncontrolled prospective single-center study. 10 adult patients with severe exacerbation of seasonal AR due to birch pollen were selected to study. All of them received the 3rd line of therapy according to FCG and had absence or incomplete control: TNSS (Total nasal symptom score) 2. All of them were treated with the omalizumab, dose and regime were prescribed according to instruction take into account the overall IgE level and the patient's weight. Daily symptom diaries and need for rescue medication were evaluated. The primary endpoint was a decrease in the Combined medical and symptom score (CMSS) mean. Results: the additional omalizumab treatment has improved AR control for all patients and has reduced the rescue medication (TNSS 1.8 [95% CI 1.562.04]; p0.001 and CMSS 2.12 [95% CI 1.742.5]; p0.001 by the end of 1 wk after the first omalizumab injection; TNSS 2.53 [95% CI 2.053.01]; p0.0001 and CMSS 5.22 [95% CI 4.74-5.7]; p0.001 by the end of 4 wk, respectively) . It was noted that the omalizumab effect realization occurs for some time (from 3 to 7 days). Due to short season pollen for birch (1-2 month) the duration of treatment in our study did not exceed 1 month, so we managed to achieve complete control over the symptoms in all patients by the omalizumab with a small multiplicity of injections (1-2). No adverse events were registered during study. Conclusion: omalizumab additional therapy in patients with severe exacerbation of AR allows to achieving the whole symptoms control. Taking into account the mechanism omalizumab should be administered at least a week before the expected pollen season in patients with severe exacerbation (according to the previous seasons) which did not complete the allergen-specific immunotherapy in a timely manner, and continue therapy for the end of the pollen season.
奥玛珠单抗在季节性变应性鼻炎严重加重中的应用
背景:根据联邦临床指南(Federal Clinical Guidelines, FCG),重度持续性变应性鼻炎(AR)和/或严重加重且三线药物治疗(抗组胺药、白三烯受体拮抗剂、鼻皮质类固醇)无效的患者建议考虑使用奥玛珠单抗,但对于季节性AR严重加重的奥玛珠单抗治疗方案和持续时间尚无实用的建议。本研究对花粉季节严重加重的AR患者进行omalizumab附加治疗,以评估疗效并确定最佳方案和治疗持续时间。材料和方法:这是一项开放观察、非对照、前瞻性单中心研究。选择10例因桦树花粉引起的季节性AR严重加重的成年患者进行研究。所有患者均按照FCG标准接受第三线治疗,且没有或不完全控制:TNSS(总鼻症状评分)2。所有患者均采用omalizumab治疗,剂量和治疗方案均根据患者总体IgE水平和体重指示进行。评估每日症状日记和抢救用药需求。主要终点是医学和症状综合评分(CMSS)平均值的下降。结果:额外的omalizumab治疗改善了所有患者的AR控制,并减少了抢救用药(TNSS 1.8 [95% CI 1.562.04];p0.001, CMSS 2.12 [95% CI 1.742.5];第一次奥玛单抗注射后1周结束时P0.001;TNSS 2.53 [95% ci 2.053.01];p0.0001和CMSS 5.22 [95% CI 4.74-5.7];4周结束时P0.001)。值得注意的是,omalizumab效果的实现需要一段时间(从3到7天)。由于桦树花粉季节短(1-2个月),我们的研究疗程不超过1个月,因此我们通过注射次数小的omalizumab实现了对所有患者症状的完全控制(1-2)。研究期间未发生不良事件。结论:奥玛单抗加药治疗急性加重期AR患者可实现整体症状控制。考虑到机制,对于未及时完成过敏原特异性免疫治疗的严重加重患者,应在预期花粉季节前至少一周(根据以往季节)给予omalizumab,并继续治疗至花粉季节结束。
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