Pediatric Pneumology and Allergology unit, Medical University of Augsburg, Augsburg, Germany.
Department of Pediatrics, Medical University of Vienna, Vienna, Austria.
Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.
Although 5-grass pollen sublingual immunotherapy has a good safety profile in controlled clinical trials, additional safety information among pediatric patients in a real-world setting would be useful.
To further document the safety of 5-grass tablet among children aged 5 to 9 years with allergic rhinoconjunctivitis (ARC).
This multicenter, observational study included allergy immunotherapy-naïve 5- to 9-year-old children with grass pollen-induced ARC prescribed with 5-grass tablet daily (3-day dose escalation to 300 index of reactivity [IR]). Patients were followed up daily for safety and tolerability over the first 30 treatment days. Adverse events (AEs) and adverse drug reactions (ADRs) were analyzed descriptively.
Three hundred seven children (mean age, 7.1 years) were enrolled. Fifty-eight percent were confirmed as polysensitized, and 36% had mild-to-moderate asthma. Of 307 patients, 233 (76%) reported AEs, and 173/307 (56%) reported ADRs, most frequently mild application-site reactions (throat irritation, oral pruritus, oral paresthesia). Sixteen of 307 (5.2%) patients withdrew because of ADRs. In 143 of 173 (83%) patients, ADRs first occurred within 1 week of starting treatment. More than half of the ADRs lasted less than 2 days, and ADRs resolved spontaneously in 161 of 173 (93%) patients. Recurrences of ADRs were reported in 45 of 173 (26%) patients and were also mainly application-site reactions. No notable differences were found in ADRs related to whether patients had asthma at inclusion. Neither epinephrine use nor admission to intensive care unit was reported.
The safety profile of 5-grass tablet in pediatric ARC patients aged 5 to 9 years was consistent with safety findings in older patients, most ADRs being at the application site and mild to moderate. ClinicalTrials.gov identifier: NCT02295969; EUPAS registration number: 8104.
尽管在对照临床试验中，5 草花粉舌下免疫治疗具有良好的安全性，但在现实环境中，儿科患者的额外安全性信息将是有用的。
进一步记录 5 草片剂在 5 至 9 岁患有过敏性鼻结膜炎（ARC）的儿童中的安全性。
这项多中心观察性研究纳入了对花粉过敏免疫疗法-naive 的 5 至 9 岁儿童，每日给予 5 草片剂（3 天剂量递增至 300 反应指数[IR]）。在最初的 30 个治疗天内，每天对患者进行安全性和耐受性监测。对不良事件（AE）和药物不良反应（ADR）进行描述性分析。
共纳入 307 名儿童（平均年龄为 7.1 岁）。58%的儿童被确认为多敏化，36%的儿童患有轻至中度哮喘。307 名患者中，有 233 名（76%）报告了 AE，173/307 名（56%）报告了 ADR，最常见的是轻度局部反应（咽喉刺激、口腔瘙痒、口腔感觉异常）。307 名患者中有 16 名（5.2%）因 ADR 而退出。173 名患者中有 143 名（83%）的 ADR 首次发生在开始治疗的 1 周内。超过一半的 ADR 持续时间不到 2 天，173 名患者中有 161 名（93%）的 ADR 自行缓解。173 名患者中有 45 名（26%）报告了 ADR 的复发，并且也主要是局部反应。纳入时有哮喘的患者的 ADR 无明显差异。没有报告肾上腺素使用或入住重症监护病房的情况。
5 草片剂在 5 至 9 岁 ARC 患儿中的安全性与老年患者的安全性发现一致，大多数 ADR 发生在应用部位，为轻度至中度。临床试验.gov 标识符：NCT02295969；EUPAS 注册号：8104。
