Schwab Jan-Alexander, Wolf Hendrik, Schnitker Jörg, Wüstenberg Eike
Schwab and Schwab Interdisciplinary Therapy Center, 81539, Munich, Germany.
Clinical Development, ALK-Abelló Arzneimittel GmbH, 22763, Hamburg, Germany.
Pulm Ther. 2018 Jun;4(1):45-57. doi: 10.1007/s41030-018-0050-1. Epub 2018 Feb 8.
Intra-seasonal start of treatment with the SQ grass sublingual immunotherapy (SLIT) tablet (GRAZAX, ALK, Denmark) has been previously demonstrated to be well-tolerated. The objective of our study was to investigate the tolerability of intra-seasonal start of treatment comparing patients treated by allergists and general practitioners experienced in treatment of allergy (GPs).
In a non-interventional, open-label, observational study, data on intra-seasonal start with the SQ grass SLIT tablet were recorded in patients treated by allergists and GPs in Germany. Adverse events (AEs) were recorded by the physicians at first administration and during the 1-3-month observation period. The tablets taken and any AEs were recorded by the patients in diaries for the first 14 days.
Treatment with the SQ grass SLIT tablet was started in 198 patients, and in 179 intra-seasonal (allergists: 140, GPs: 39) and 19 post-seasonal; average treatment period was 47 days. AEs related to intra-seasonal start were reported in 43.6% of patients; no relevant differences between allergists and GPs were observed. In the subgroup of GPs, patients were younger (p = 0.0191), had more frequently asthma (p = 0.0043), more patients used symptomatic medication in the previous pollen season (p = 0.0198) and were more frequently treated for other diseases (p = 0.0467). In the allergists subgroup, more diagnostic allergy tests were applied (p < 0.0001) with less anti-allergic premedication at first administration (p = 0.0026).
The intra-seasonal start of treatment with the SQ grass SLIT tablet in patients routinely treated by allergists or GPs with experience in treatment of allergy was well-tolerated, although patient characteristics were different with respect to age, frequency of asthma and concomitant allergies, use of symptomatic medication in the previous grass pollen season and concomitant treatment of other diseases. The safety profile from a previous placebo-controlled clinical trial and data from a previous real-life study on intra-seasonal start performed by allergists were confirmed.
先前已证明，季节性开始使用SQ草舌下免疫疗法（SLIT）片剂（GRAZAX，ALK，丹麦）治疗耐受性良好。我们研究的目的是比较由过敏症专科医生和有过敏症治疗经验的全科医生（GPs）治疗的患者，季节性开始治疗的耐受性。
在一项非干预性、开放标签的观察性研究中，记录了德国过敏症专科医生和全科医生治疗的患者季节性开始使用SQ草SLIT片剂的数据。医生在首次给药时和1至3个月的观察期内记录不良事件（AE）。患者在日记中记录最初14天服用的片剂和任何AE。
198例患者开始使用SQ草SLIT片剂治疗，其中179例为季节性开始治疗（过敏症专科医生：140例，全科医生：39例），19例为季节后开始治疗；平均治疗期为47天。43.6%的患者报告了与季节性开始治疗相关的AE；未观察到过敏症专科医生和全科医生之间的相关差异。在全科医生亚组中，患者更年轻（p = 0.0191），哮喘发生率更高（p = 0.0043），更多患者在前一个花粉季节使用过对症药物（p = 0.0198），并且接受其他疾病治疗的频率更高（p = 0.0467）。在过敏症专科医生亚组中，应用的诊断性过敏试验更多（p < 0.0001），首次给药时使用的抗过敏预处理药物更少（p = 0.0026）。
在由有过敏症治疗经验的过敏症专科医生或全科医生常规治疗的患者中，季节性开始使用SQ草SLIT片剂治疗耐受性良好，尽管患者在年龄、哮喘频率和合并过敏症、前一个草花粉季节使用对症药物情况以及其他疾病的合并治疗方面存在差异。先前安慰剂对照临床试验的安全性概况以及过敏症专科医生先前进行的一项关于季节性开始治疗的真实生活研究的数据得到了证实。
