HDM allergy is the prevailing condition in subjects allergic to inhalants. Clinical studies with HDM extracts have long been characterized by small sample size, varying allergen doses, and poorly defined endpoints assessing disease severity.
Well-designed, randomized, controlled studies recruiting thousands of patients have been conducted with newly developed HDM sublingual tablets that were done in the last decade. Clinical efficacy has been evaluated in randomized, double-blind, placebo-controlled trials. Both endpoints related to “present” asthma control as well as endpoints related to “future” asthma control were included in these studies, in agreement with GINA guidelines. SQ®-HDM SLIT-tablets were approved Europe-wide as a 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. SLIT-tablet-based immunotherapy was included in the 2017 GINA guidelines as an “add-on” treatment for asthmatic patients sensitized to HDM.
The study concluded through its findings that 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.