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Safety and tolerability of an intra-seasonal initiation of the sq-standardised grass allergy immunotherapy tablet: A non-interventional observational study investigating the feasibility during routine administration

机译：sq标准化草过敏免疫治疗片的季节内启动的安全性和耐受性：一项非常规观察性研究，研究常规给药期间的可行性

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Background and Objective: For specific immunotherapy to pollen allergy, a pre-seasonal start of treatment is recommended by international guidelines. In a placebo-controlled clinical trial with adults, an intra-seasonal start of therapy with the SQ-standardised grass allergy immunotherapy tablet (AIT) was well-tolerated. The objective of our study was to investigate the feasibility of an intra-seasonal start of grass AIT administered during routine treatment by practising allergists. Methods: In a multicentre, prospective, open-label, uncontrolled, non-interventional observational study, data on routine treatment with grass AIT were recorded in patients who started administration of tablets within the 2010 grass pollen season in Germany. Adverse events (AEs) were recorded by the physician at visits for the first administration in the clinic and at the end of the 1- to 3-month observation period. AEs and daily administration of the tablet were recorded by the patients in diaries for the first 14 days. Treatment satisfaction, global tolerability and perceived effect of treatment were assessed by the patient and physician at the end of the study. Results: A total of 662 patients were treated with 1 tablet daily by 286 physicians. Grass AIT was started intra-seasonally in 620 patients and post-season in 42. The average treatment period was 51.6 days. AEs were recorded in 52.1 % of all patients and in 35.6 % at first administration, with throat irritation (21.3 %), paraesthesia oral (19.9 %), oral pruritus (14.0 %) and ear pruritus (10.3 %) being the most frequent AEs related to grass AIT. The intensity of the AEs was assessed as mild or moderate in 42.1 % of patients and severe in 8.0 %; AEs related to grass AIT were classified as serious in two patients. Grass AIT was discontinued due to AEs in 7.7 % of patients. Diaries were evaluable for 77.0 % of patients; the average rate of patients with AEs decreased continuously from 44.7 % (day 1) to 26.9 % (day 14) and the average daily rate of patients who forgot to take their tablet was about 5 %. Overall tolerability was assessed by 87.2 % of patients and 91.4 % physicians as "very good" or "good" and effectiveness of treatment was assessed as "very good" or "good" in 81.4 % of patients and 85.8 % of physicians. More than 90 % of patients and physicians were satisfied with the treatment. Conclusion: The tolerability data for an intra-seasonal start of grass AIT during routine treatment confirm the safety profile from the previous controlled trial. Tolerability was assessed as good in combination with high satisfaction with the treatment and compliance.
机译：背景与目的：对于针对花粉过敏的特异性免疫疗法，国际指南建议在季节开始前进行治疗。在一项针对成年人的安慰剂对照临床试验中，使用SQ标准化草过敏免疫治疗片（AIT）进行季节内治疗的耐受性良好。我们研究的目的是研究在常规治疗期间由变应性过敏者施用草AIT的季节内开始的可行性。方法：在一项多中心，前瞻性，开放标签，非对照，非干预性观察性研究中，记录了在德国2010年草粉花粉季节内开始服用片剂的患者中使用草AIT进行常规治疗的数据。在首次就诊时以及在1至3个月观察期结束时，医生在就诊时记录了不良事件（AE）。患者在头14天的日记中记录了AEs和片剂的每日给药量。在研究结束时，患者和医师对治疗满意度，总体耐受性和治疗效果进行了评估。结果：总共662名患者由286位医生每天接受1片药片的治疗。 620例患者在季节内开始使用草类AIT，42例患者在季节后开始使用。平均治疗时间为51.6天。在所有患者中，有AE发生率为52.1％，首次给药时为35.6％，其中最常见的AE是咽喉刺激性（21.3％），口腔感觉异常（19.9％），口腔瘙痒（14.0％）和耳痒（10.3％）与草AIT有关。 AEs的强度在42.1％的患者中为轻度或中度，在8.0％的患者中为重度;与草AIT相关的AE被分类为2例严重。 7.7％的患者因不良事件而停用Grass AIT。日记可评估77.0％的患者; AEs的平均发生率从4​​4.7％（第1天）连续下降到26.9％（第14天），而忘记服用片剂的患者的每日平均发生率约为5％。 87.2％的患者和91.4％的医生将总体耐受性评估为“非常好”或“好”，81.4％的患者和85.8％的医生将治疗的有效性评估为“非常”或“良好”。超过90％的患者和医师对治疗感到满意。结论：常规治疗期间季节内开始草AIT的耐受性数据证实了先前对照试验的安全性。耐受性被评估为良好，同时对治疗和依从性的满意度很高。

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