Real-World Safety and Efficacy Clinical Data of an Improved Allergen-Specific Immunotherapy Product for the Treatment of Bee Venom Allergy

• Published in: Vaccines (Basel) Vol. 11; no. 5; p. 979
• Main Authors: Gonzalez Guzman, Luis Alfredo, García Robaina, Jose Carlos, Barrios Recio, Javier, Escudero Arias, Elena, Liñares Mata, Tania, Cervera Aznar, Raquel, De La Roca Pinzón, Federico, Miguel Polo, Lissette Del Carmen, Arenas Villarroel, Luis, López Couso, Verónica P, Alcover Diaz, Javier, Rodriguez Gil, David, Pelaez, Ricardo Palacios, Carballada Gonzalez, Francisco Javier
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 13.05.2023; MDPI
• Subjects: Allergens; Allergies; allergy immunotherapy; Api m 10; Bee venom; Bees; Biomarkers; Cardiac arrhythmia; Complications and side effects; Disease; Effectiveness; Health aspects; Health services; Heart attacks; human serum albumin; hymenoptera venom; Immunotherapy; Patient outcomes; Patients; Proteins; Pruritus; Side effects; Skin tests; Stings; Urticaria; vaccines; Venom; Spain; Api m 10; allergy immunotherapy; vaccines; human serum albumin; hymenoptera venom; bee venom
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines11050979

The aim of this study is to explore the safety and efficacy of bee venom immunotherapy without HSA, in real-life patients. Methods: This is an observational retrospective study developed in seven hospitals in Spain, where patients treated with this immunotherapy were included. They gathered the protocol used to initiate the immunotherapy, adverse reactions, field re-stings, and the patient clinical data (clinical history, biomarkers, and skin prick test). Results: A total of 108 patients were included. In total, 4 protocols were used (5 weeks reaching 200 μg, and 4, 3, and 2 weeks reaching 100 μg). An incidence of systemic adverse reactions for each 100 injections of 1.5, 1.7, 0, and 0.58, respectively, was found. The demographic data showed not to directly affect the appearance of adverse reactions, except for those having a grade 2 systemic reaction with immunotherapy previously had a grade 4 systemic reaction; the IgE to Apis mellifera was 3 times higher in patients with systemic reactions of grade 1 than in the general group, and other specific IgEs were lower in those with systemic reactions. Most of the patients recognized Api m 1 followed by Api m 10. In the sample, 32% experienced spontaneous re-stings, without presenting systemic reactions, after a year of treatment.