Schwab and Schwab Interdisciplinary Therapy Center, Munich, Germany.
Clin Drug Investig. 2013 Oct;33(10):719-26. doi: 10.1007/s40261-013-0115-8.
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.
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.
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.
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.
对于花粉过敏的特异性免疫治疗，国际指南建议在季节前开始治疗。在一项针对成人的安慰剂对照临床试验中，接受 SQ 标准化草过敏免疫治疗片（AIT）的季节内治疗耐受良好。我们的研究目的是调查在常规治疗中由执业过敏医生进行季节内开始草 AIT 的可行性。
在一项多中心、前瞻性、开放标签、非干预性观察研究中，记录了德国在 2010 年草花粉季节内开始服用片剂的患者的常规草 AIT 治疗数据。医生在诊所首次就诊时和 1-3 个月观察期结束时记录不良事件（AE）。患者在首次服用的前 14 天通过日记记录 AE 和每日片剂的使用情况。在研究结束时，患者和医生评估治疗满意度、总体耐受性和治疗效果。
共有 662 名患者由 286 名医生接受每日 1 片治疗。620 名患者在季节内开始治疗，42 名患者在季节后开始治疗。平均治疗期为 51.6 天。所有患者中有 52.1%出现 AE，首次就诊时为 35.6%，最常见的与草 AIT 相关的 AE 为咽喉刺激（21.3%）、口腔感觉异常（19.9%）、口腔瘙痒（14.0%）和耳瘙痒（10.3%）。42.1%的患者 AE 严重程度评估为轻度或中度，8.0%的患者 AE 严重程度评估为重度；两名患者的草 AIT 相关 AE 被归类为严重。由于 AE，7.7%的患者停止使用草 AIT。77.0%的患者的日记可评估；出现 AE 的患者比例从第 1 天的 44.7%持续下降到第 14 天的 26.9%，每天忘记服药的患者比例平均约为 5%。87.2%的患者和 91.4%的医生总体上评估治疗耐受性为“非常好”或“好”，81.4%的患者和 85.8%的医生评估治疗效果为“非常好”或“好”。超过 90%的患者和医生对治疗满意。
季节内开始常规治疗草 AIT 的耐受性数据证实了之前对照试验的安全性概况。在与治疗满意度高和顺应性好相结合的情况下，耐受性评估为良好。
