Safety of subcutaneous and sublingual immunotherapy with allergoids in children: a real-life pharmacovigilance study

Aims: 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. Materials & methods: 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. Results & conclusion: 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. The cure for allergic people is named allergen-specific immunotherapy (AIT). Recently, AIT uses new substances named allergoids. This study has shown that AIT with allergoids is very safe. Allergen immunotherapy using carbamylated monomeric allergoids is safe as the number of adverse reactions is negligible.

Automated summary

This study evaluated the safety of allergen-specific immunotherapy using carbamylated monomeric allergoids and found that adverse reactions were extremely rare. Both sublingual and subcutaneous routes of administration were shown to have excellent safety profiles in children.