Department of Dermatology and Allergology, Technical University of Munich, Munich, Germany.
Clinical Unit Allergology, Helmholtz Zentrum Munich, German Research Center for Environmental Health GmbH, Munich, Germany.
Allergy. 2021 Dec;76(12):3733-3742. doi: 10.1111/all.14882. Epub 2021 May 15.
The standardized quality (SQ) tree sublingual immunotherapy (SLIT)-tablet has recently been approved for treatment of tree pollen allergy. Healthcare workers should be provided with detailed safety data for clinical use.
To assess the tolerability and safety of the SQ tree SLIT-tablet (12 SQ-Bet) in adults and adolescents.
Safety data were pooled from three double-blinded, randomized, placebo-controlled trials (2 phase-II/1 phase-III) including adults and adolescents 12-65 years with allergic rhinitis and/or conjunctivitis treated before and during one pollen season once-daily with 12 SQ-Bet (n = 471) or placebo (n = 458): EudraCT no: 2012-000031-59; NCT02481856; EudraCT 2015-004821-15.
The most frequently reported investigational medicinal product (IMP)-related AEs with 12 SQ-Bet were oral pruritis (39% of subjects) and throat irritation (29%). IMP-related AEs were mainly mild or moderate in severity, and the majority resolved without treatment and did not lead to treatment interruption/discontinuation. With 12 SQ-Bet, oral pruritus was more frequent among subjects with pollen food syndrome (PFS) (45%) than without PFS (29%). The 12 SQ-Bet did not seem to induce an increased risk of asthma: 7 events were reported in 7 subjects with 12 SQ-Bet and 11 in 10 subjects with placebo. No differences were seen in the risk of moderate-to-severe IMP-related AEs regardless of age, PFS status and asthma medical history.
The 12 SQ tree SLIT-tablet was well tolerated in tree pollen allergic subjects with no major safety concerns detected. This safety profile supports daily at-home sublingual administration once the first dose is tolerated when administered under medical supervision.
标准化质量（SQ）舌下免疫治疗（SLIT）片最近已被批准用于治疗花粉过敏。应向医疗保健工作者提供详细的安全性数据以用于临床使用。
评估成人和青少年使用 SQ 树 SLIT 片（12 SQ-Bet）的耐受性和安全性。
安全性数据来自三项双盲、随机、安慰剂对照试验（2 项 II 期/1 项 III 期），共纳入 12-65 岁有花粉过敏史的成人和青少年患者，这些患者在一个花粉季节前和花粉季节期间每日一次接受 12 SQ-Bet（n=471）或安慰剂（n=458）治疗：EudraCT 编号：2012-000031-59；NCT02481856；EudraCT 2015-004821-15。
12 SQ-Bet 最常报告的与研究药物相关的不良事件（AE）为口腔瘙痒（39%的受试者）和咽喉刺激（29%）。与 12 SQ-Bet 相关的 AE 主要为轻度或中度，大多数无需治疗即可缓解，且不会导致治疗中断/停止。有花粉食物综合征（PFS）的受试者中，12 SQ-Bet 相关的口腔瘙痒更为常见（45%），而无 PFS 的受试者中为 29%。12 SQ-Bet 似乎不会增加哮喘的风险：在接受 12 SQ-Bet 治疗的 7 名受试者中报告了 7 例事件，在接受安慰剂治疗的 10 名受试者中报告了 11 例事件。无论年龄、PFS 状态和哮喘病史如何，与 12 SQ-Bet 相关的中重度 AE 风险均无差异。
在花粉过敏的受试者中，12 SQ 树 SLIT 片耐受性良好，未发现重大安全性问题。该安全性特征支持在医疗监督下首次耐受剂量后，每日在家中进行舌下给药。
