Medical Department, Lofarma S.p.A., Milan, Italy.
Outpatients Depatrment, Allergy Center, Casa di Cura Villa Montallegro, 16145, Via Montezovetto, Genoa, Italy.
Immunotherapy. 2024 Jan;16(1):43-53. doi: 10.2217/imt-2023-0126. Epub 2023 Nov 29.
Allergen-specific immunotherapy uses a sublingual (sublingual immunotherapy [SLIT]) or subcutaneous (subcutaneous immunotherapy [SCIT]) route. This pharmacovigilance study aimed to determine the number and type of adverse drug reactions (ADRs) for SLIT and SCIT using carbamylated monomeric allergoids (CMAs) in children. This pharmacovigilance study analyzed real-world post-marketing reports collected from a safety database of Lais sublingual tablets and injective Lais-in, containing CMAs for over 10 years. From January 2009 to September 2022, 26,107 doses of Lais-in were administered in children; only two nonserious related ADRs (incidence: 0.000077%) were reported. Regarding SLIT, the results showed only 12 spontaneous nonserious ADR reports (incidence: 0.000004%). These data showed the excellent safety profile of both SLIT and SCIT CMAs.
变应原特异性免疫治疗采用舌下（舌下免疫治疗 [SLIT]）或皮下（皮下免疫治疗 [SCIT]）途径。本药物警戒研究旨在确定使用氨甲酰化单克隆变应原（CMAs）在儿童中进行 SLIT 和 SCIT 的不良反应（ADR）的数量和类型。本药物警戒研究分析了从 Lais 舌下片剂和含 CMAs 的注射用 Lais-in 的安全数据库中收集的上市后真实世界报告，这些报告已收集超过 10 年。从 2009 年 1 月至 2022 年 9 月，26107 剂 Lais-in 在儿童中使用；仅报告了两例非严重相关的不良反应（发生率：0.000077%）。关于 SLIT，结果显示仅报告了 12 例自发性非严重不良反应报告（发生率：0.000004%）。这些数据表明 SLIT 和 SCIT CMAs 的安全性良好。
