Raúl Lázaro Castro Almarales, MD
,
Allergens Department, National Center of Bioproducts (BIOCEN), Allergology and General Integral Medicine, La Habana, Cuba
Mirta Alvarez Castello, MD
,
Allergology Department, University Hospital General Calixto García, WAO Member, Cuban Society of Allergy , Asthma and Clinical Immunology, Member, Cuban Society of Immunology Member, Havana, Cuba
Mercedes Ronquillo Díaz
,
Allergen Service, University Hospital "General Calixto García", Specialist Second Degree in Allergology, Cuba
Mayda González León, MD
,
Docent Polyclinic "Pedro Fonseca", Cuban Society of Integral General Medicine Member, Cuban Society of Allergy , Asthma and Clinical Immunology, Member, Cuban Society of Immunology Member,, Havana, Cuba
Alexis Labrada Rosado, PhD
,
WAO Member, Cuban Society of Immunology, Cuban Society of Allergy, Asthma and Clinical Immunology, Mayabeque, Cuba
José Severino Rodríguez Canosa, MD
,
Allergen Service, University Hospital "General Calixto García", WAO Member, Cuban Society of Immunology, Cuban Society of Allergy, Asthma and Clinical Immunology, Havana, Cuba
Bárbara Ivonne Navarro Viltres, MD
,
Docent Polyclinic "Federico Capdevila", WAO Member, Cuban Society of Allergy, Asthma and Clinical Immunology, Havana, Cuba
Yunia Oliva Diaz
,
Allergen Department, National Center of Bioproducts (BIOCEN), Cuban Society of Immunology, Cuban Society of Allergy, Asthma and Clinical Immunology, Mayabeque, Cuba
Maytee Mateo Morejón
,
Allergen, Biocen, Cuba
Background: Subcutaneous allergen-specific immunotherapy is burdened with the risk of severe systemic reactions; therefore, sublingual administration route has been increasingly investigated worldwide. The goal was to assess the therapeutic effect and safety of allergen therapeutic vaccines of
Dermatophagoides pteronyssinus,
Dermatophagoides siboney and
Blomia tropicalis House-Dust mites (VALERGEN, BIOCEN, Cuba) by sublingual route, in asthmatic patients.
Methods: Three Double-Blind Placebo-Controlled clinical trials were performed in 40 patients each, showing asthmatic symptoms and positive predominant Skin Prick Test (SPT) to each mite, respectively. Half of subjects were randomized to placebo. Patients received the treatment consisting on sublingual drops with increasing daily doses for 3 weeks and maintenance doses (2000 BU) twice a week until 12 moths. Therapeutic effect was assessed after 6 and 12 months using symptoms/medication diary cards, peak expiratory flow (PEF) measures and skin sensitivity to investigated mites. Adverse reactions were classified using the World Allergy Organization scale.
Results: The treatment reduced significantly (p<0.01) clinical symptoms (38%, CI95%: 33-44) and medication intake (26%, CI95%:21-32) with respect to placebo. The skin sensitivity to the allergens decreased also significantly (p<0.01). The allergen amount needed to induce a positive SPT increased 52-fold. PEF variability decreased also significantly (p<0.05). The treatment was considered effective in 77% of patients. A major advantage as compared to subcutaneous route was a remarked lower frequency of adverse effects. Local reactions were noted only in 0.43% of administrations. No systemic reactions were observed.
Conclusions: Summarizing sublingual immunotherapy using VALERGEN vaccines is effective and safe in mite-sensitive asthmatic patients.
