Bernstein David I, Bardelas Jose A, Svanholm Fogh Bodil, Kaur Amarjot, Li Ziliang, Nolte Hendrik
a Bernstein Clinical Research Center and Department of Medicine and Environmental Health , University of Cincinnati , Cincinnati , OH , USA.
b Allergy and Asthma Center of North Carolina , High Point , NC , USA.
Postgrad Med. 2017 Aug;129(6):590-597. doi: 10.1080/00325481.2017.1302306. Epub 2017 Mar 22.
Treatment with allergy immunotherapy improves allergic rhinoconjunctivitis, but can also improve comorbidities associated with allergic rhinitis such as asthma. Sublingual immunotherapy (SLIT)-tablets are a convenient and efficacious method of allergy immunotherapy. They are self-administered after the first tablet has been provided under medical supervision. Therapy may elicit local reactions or, rarely, systemic allergic reactions. The objective of this report is to inform healthcare practitioners about the safety and tolerability profile of SLIT-tablets and use this information to provide practical guidance that may inform patients regarding potential adverse reactions and how to manage them.
Pooled analyses of safety data from completed randomized, multicenter, double-blind, placebo-controlled phase 2 and phase 3 US and EU trials of timothy grass, short ragweed, and SQ house dust mite SLIT-tablets were conducted to characterize safety and tolerability.
SLIT-tablets are generally well tolerated. No life-threatening events, serious systemic allergic reactions, or events that compromised the airway have been reported. The most common treatment-related adverse events (AEs) are oral site reactions, most of which begin on day 1 of treatment, recur for less than 2 weeks, and resolve after approximately 30-60 minutes. Systemic allergic reactions have been managed with conventional pharmacotherapy. Reactions treated with epinephrine are uncommon, but have been reported. Treatment of AEs, treatment discontinuation considerations, and patient FAQs regarding SLIT-tablet safety/tolerability are discussed.
This report gives healthcare providers valuable information to educate patients regarding what to expect in terms of SLIT-tablet safety and tolerability. Practical guidance is also provided to ensure proper treatment of any adverse reactions.
变应性免疫疗法可改善变应性鼻结膜炎，还能改善与变应性鼻炎相关的合并症，如哮喘。舌下免疫疗法（SLIT）片剂是一种方便有效的变应性免疫疗法。在医生监督下提供第一片药后，患者可自行给药。治疗可能引发局部反应，或很少见的全身性过敏反应。本报告的目的是向医疗从业者通报SLIT片剂的安全性和耐受性概况，并利用这些信息提供实用指导，告知患者可能出现的不良反应及应对方法。
对美国和欧盟已完成的关于梯牧草、豚草和尘螨SLIT片剂的随机、多中心、双盲、安慰剂对照2期和3期试验的安全性数据进行汇总分析，以描述其安全性和耐受性。
SLIT片剂总体耐受性良好。未报告危及生命的事件、严重的全身性过敏反应或影响气道的事件。最常见的与治疗相关的不良事件（AE）是口腔局部反应，大多数在治疗第1天开始，持续复发少于2周，约30 - 60分钟后消退。全身性过敏反应已通过传统药物治疗。用肾上腺素治疗的反应不常见，但有报告。讨论了AE的治疗、停药考虑因素以及患者关于SLIT片剂安全性/耐受性的常见问题解答。
本报告为医疗服务提供者提供了有价值的信息，以教育患者关于SLIT片剂安全性和耐受性的预期情况。还提供了实用指导，以确保对任何不良反应进行适当治疗。
