The Safety of Carbamylated Monomeric Allergoids for Sublingual Immunotherapy. Data from a Pharmacovigilance Study

Abstract

Aim: Sublingual immunotherapy (SLIT) is significantly less concerned by systemic reactions than subcutaneous immunotherapy. Allergoids were introduced to reduce systemic reaction to subcutaneous immunotherapy, but may also be used for SLIT. Methods: This pharmacovigilance study evaluated the post-marketing reports collected in a safety database, including the number and the type (serious or not serious) of adverse drug reactions (ADRs) in Italy by SLIT with the carbamylated monomeric allergoid (CMA). Results: More than 15,000,000 CMA tablets were administered, with 25 spontaneous reports of ADRs, only two being serious. Conclusion: The rate of ADRs to CMA we found in this pharmacovigilance survey, corresponding to 0.0004% of all administered doses, is far lower than the rates commonly reported for allergen SLIT products.

Real-Life Effectiveness of Subcutaneous Immune Therapy with Carbamylated Monomeric Allergoids on Mite, Grass, and Pellitory Respiratory Allergy: A Retrospective Study

“…The safety profile of the allergoids used in this study is based on chemical modification by monomeric carbamylation, which causes allergen lysine substitution with preserved size and structural conformation of the native allergen but with a low capacity to link IgE to its specific receptor [51], while maintaining immunogenicity [52][53][54][55]. There are many reports showing that both SLIT and SCIT with carbamylated monomeric allergens are safe as well as effective [28,[56][57][58][59][60].…”

“…In fact, they are significantly less allergenic than native ones due to a decreased capacity to bind IgE to its specific receptor while maintaining immunogenicity and thus their therapeutic efficacy. A pharmacovigilance study [28] showed that the rate of adverse reactions to monomeric allergoid-based AIT corresponds to 0.0004% of the doses administered, both local and mild, far below the commonly reported rates for native allergen AIT products, for which anaphylactic reactions have been reported in some cases [29].…”

Allergen Immunotherapy management during vaccinations: An international survey

“…In this regard, a recent study analysed the pharmacovigilance data of an allergoid and reported a meagre rate of adverse reactions. 12 Consistently, another recent paper underlined that the choice of SLIT compounds should minimize the risk of severe adverse events, mainly concerning anaphylaxis. 13 This web-based survey had some methodological biases, including the limited number of involved countries, and the selection of participants.…”

Allergen Immunotherapy in the Era of SARS-CoV-2

“…Moreover, SLIT is already an option in those patients who had systemic reactions after injections and it is expected that patients already tolerating SCIT have developed sufficient tolerance against the culprit allergen that would suggest a seamless transition to SLIT. Finally, alternative formulations with no history of anaphylactic reactions exist, consisting of chemically modified extracts (allergoids) with well-established use, evidence of immunological anti-inflammatory action and clinical benefit [12,13]. In addition, for some SLIT preparations with high safety profile, the build-up phase can be skipped to facilitate patients who are asked to independently manage the therapy at home [14].…”