New perspectives in allergen specific immunotherapy driven by big trials with house dust mite sublingual SQ® tablets.

House-dust mites (HDM) allergy is the prevailing condition in subjects allergic to inhalants. Clinical studies with HDM extracts-either subcutaneous (SCIT) or sublingual (SLIT) have long been characterized by small sample size, varying allergen doses, and poorly defined endpoints assessing disease severity. In the last decade, well-designed, randomized, controlled studies recruiting thousands of patients have been conducted with newly developed HDM sublingual tablets (SQ®-HDM tablets). This drug is easily dispersible in the oral cavity due to the patented Zydis® technology and its allergen composition is balanced in terms of group I and group II major mite allergen content, reflecting the equal contribution of the two components to HDM sensitization. HDM is the most common allergen associated with asthma. Clinical efficacy of the SQ® HDM SLIT-tablet in HDM allergic asthma has been evaluated in randomized, double-blind, placebo-controlled trials. Both endpoints related to "present" asthma control (inhaled corticosteroid-ICS) as well as endpoints related to "future" asthma control (occurrence of asthma exacerbations) were included in these studies, in agreement with GINA (Global Initiative for Asthma) guidelines. Based on the positive results of these studies, SQ®-HDM SLIT-tablets were approved Europe-wide as registered drug for treating moderate-to-severe allergic rhinitis with or without allergic asthma and not well controlled HDM allergic asthma, associated with allergic rhinitis of any severity. GINA guidelines in 2017 included SLIT-tablet-based immunotherapy as an "add-on" treatment for asthmatic patients sensitized to HDM; indeed, allergen immunotherapy (AIT) is considered to be a complementary treatment option that targets the immunological of allergic diseases, representing the only treatment potentially disease-modifier or, at least, with a long-term efficacy. The availability of a safe, standardized, registered treatment for HDM respiratory allergies is pivotal in the immunotherapy field, pushing it out of a century-long limbo of amatorial interest towards the full dignity deserved by the only casual treatment of respiratory allergies.