BACKGROUND AND OBJECTIVES:GRAZAX(®) (Phleum Pratense, 75,000 SQ-T/2,800 BAU, ALK, Denmark), an SQ-standardized grass allergy sublingual immunotherapy tablet for the desensitization of grass pollen-induced rhinoconjunctivitis, has been developed to facilitate patient access to specific immunotherapy (SIT), while minimizing the risk of serious treatment-related adverse events. As a minimum duration of 3 years is recommended for SIT treatment, the GRAAL trial aimed to assess the safety profile of GRAZAX(®) in real-world conditions during long-term treatment of patients with grass pollen-induced allergic rhinoconjunctivitis (ARC). METHODS:A multicentre, prospective, open-label, observational trial was conducted over three consecutive grass pollen seasons from November 2007 to October 2010 in France. A total of 130 physicians included 628 patients with previously documented ARC. Patients received one tablet daily (no up-titration) for at least 4 months before the expected start of the pollen season (pre-season), which was then maintained throughout the entire season (co-season). The primary endpoint was safety and tolerability (immediate, i.e. each year at first tablet administration, and long-term) after pre- and co-seasonal exposure to GRAZAX(®). RESULTS:Patients were treated for an average of 5.5 months per year. After administration of the first tablet, immediate tolerable reactions (defined as benign, local, of short duration [<30 minutes] and not requiring any symptomatic treatment) were experienced by 54.6%, 38.4% and 33.6% of the patients during the first, second and third years of treatment, respectively. Immediate intolerable reactions (required study discontinuation, symptomatic medication or lasted >30 minutes) occurred in 14 patients (2.2%) during GRAZAX(®) initiation, and one patient (0.3%) at treatment reintroduction during the second year. Adverse events considered to be related to GRAZAX(®) were reported by 46.2%, 14.4% and 1.8% of patients, during the first, second and third years of treatment, respectively. The most frequently reported adverse events were mild-to-moderate local events (at the oral and pharyngeal mucosa levels). These symptoms mainly occurred within the first month of treatment initiation and subsequent tablet reintroduction. CONCLUSION:Daily administration of GRAZAX(®) for three consecutive years was generally safe and well tolerated. An improvement in the incidence of adverse events related to treatment was observed at reintroduction of GRAZAX(®) and during the course of treatment. TRIAL REGISTRATION:http://clinicaltrials.gov (NCT01433510).

译文

背景和目的:已经开发了GRAZAX(®)(Phleum Pratense,75,000 SQ-T / 2,800 BAU,ALK,丹麦),一种用于草粉引起的鼻结膜炎脱敏的SQ标准化草过敏性舌下免疫治疗片。获得特定的免疫疗法(SIT),同时将与治疗相关的严重不良事件的风险降至最低。由于建议对SIT治疗至少持续3年,因此GRAAL试验旨在评估GRAZAX(®)在花粉诱导的变应性鼻结膜炎(ARC)患者长期治疗期间在现实条件下的安全性。
方法:从2007年11月至2010年10月,在法国连续三个季节进行了一项多中心,前瞻性,开放标签的观察性试验。总共130位医生包括628名先前记录过ARC的患者。患者在预期的花粉季节开始前(淡季前)至少每天服用4片(不滴定),然后在整个季节内均保持一整天(共同季节)。主要终点是在季节前和季节性共同暴露于GRAZAX®之后的安全性和耐受性(即立即,即每年首次服用片剂,每年一次)。
结果:患者平均每年接受5.5个月的治疗。服用第一片后,在第一片中,有54.6%,38.4%和33.6%的患者立即发生了可耐受的反应(定义为短时间[<30分钟]的良性,局部性,不需要任何对症治疗),第二年和第三年。在启动GRAZAX®的过程中,立即发生了无法忍受的反应(要求中止研究,对症药物治疗或持续> 30分钟),其中14例患者(2.2%)在第二年的重新治疗中发生了1例患者(0.3%)。在治疗的第一年,第二年和第三年,分别有46.2%,14.4%和1.8%的患者报告了与GRAZAX®相关的不良事件。最常见的不良事件是轻度至中度的局部事件(在口腔和咽粘膜水平)。这些症状主要发生在治疗开始的第一个月和随后的片剂重新引入内。
结论:GRAZAX(®)连续三年每日给药通常是安全的,并且耐受性良好。在重新引入GRAZAX®和治疗过程中,观察到了与治疗相关的不良事件发生率的改善。
试用注册:http://clinicaltrials.gov(NCT01433510)。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录