Division of Allergy & Immunology, University of South Florida, Tampa, Fla.
Allergy and Asthma Center, Fort Lauderdale, Fla.
J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1717-1727.e1. doi: 10.1016/j.jaip.2017.04.020. Epub 2017 Jul 19.
The 5-grass pollen sublingual tablet has been approved for the treatment of grass pollen-induced allergic rhinoconjunctivitis in subjects with or without intermittent asthma.
To provide a comprehensive analysis of the safety profile of the 5-grass tablet on the basis of pooled data from 8 clinical trials.
Subjects (5-65 years old) with medically confirmed grass pollen-induced allergic rhinoconjunctivitis were included in the double-blind studies. Those with intermittent asthma not requiring treatment other than inhaled beta-2 agonists could participate. Randomized subjects received a 5-grass or placebo tablet daily 2 or 4 months preseasonally and coseasonally (5 single-season studies, over 3 years in a long-term study) or outside the season (phase I studies). Adverse events were pooled and analyzed descriptively.
Among 2,512 subjects enrolled, 1,514 received the 5-grass tablet. A total of 1,038 adults and 154 pediatric (5-17 years old) subjects were treated with the 300 Index of Reactivity dose (vs 840 and 158 placebo recipients, respectively); 17% had intermittent asthma, and 62% were polysensitized. Adverse reactions (ADRs) reported in more than 10% of actively treated subjects were mild or moderate application-site reactions, for example, oral pruritus 25% (placebo 4%) and throat irritation 21% (placebo 3%). These generally occurred during the first week of treatment and decreased over time. They led to discontinuation in less than 2.5% of subjects. None of the 3 serious ADRs were reports of anaphylaxis. No notable differences were detected in terms of incidence, nature, and severity of ADRs between adult and pediatric populations, nor between subjects with or without asthma.
The pooled analysis in 1,514 subjects from 8 clinical studies demonstrates that the 5-grass pollen sublingual tablet has a similar good safety profile in adult and pediatric patients with or without mild, intermittent asthma.
5 草花粉舌下片剂已获准用于治疗花粉诱发的变应性鼻炎结膜炎，患者无论是否患有间歇性哮喘均可使用。
基于 8 项临床试验的汇总数据，全面分析 5 草片剂的安全性概况。
本双盲研究纳入了经医学确认的花粉诱发的变应性鼻炎结膜炎患者。允许间歇性哮喘患者使用吸入性β-2 激动剂进行治疗。随机分组的受试者在花粉季节前 2 或 4 个月和花粉季节期间（5 项单季节研究，在一项长期研究中持续 3 年）或在花粉季节之外（I 期研究）每天服用 5 草或安慰剂片剂。汇总并以描述性方式分析不良事件。
在纳入的 2512 名受试者中，1514 名接受了 5 草片剂治疗。共有 1038 名成年患者和 154 名儿科患者（5-17 岁）接受了 300 反应指数剂量的治疗（分别有 840 名和 158 名安慰剂接受者）；17%的患者患有间歇性哮喘，62%的患者为多敏性。在接受积极治疗的受试者中，报告的不良反应（ADR）超过 10%的为轻度或中度的应用部位反应，例如口腔瘙痒 25%（安慰剂为 4%）和咽喉刺激 21%（安慰剂为 3%）。这些反应通常发生在治疗的第一周，且随着时间的推移逐渐减少。导致停药的比例低于 2.5%。3 例严重 ADR 均非过敏反应报告。在成人和儿科人群中，以及在有或无哮喘的患者中，ADR 的发生率、性质和严重程度均无显著差异。
8 项临床试验的 1514 名受试者的汇总分析表明，5 草花粉舌下片剂在有或无轻度间歇性哮喘的成人和儿科患者中具有相似的良好安全性。
