QUANTITATIVE ASSESSMENT of the compliance with a once-daily sublingual immunotherapy regimen in real life

Allergen-specific immunotherapy given as subcutaneous injections (SCIT) remained for decades the only available administration route. SCIT is effective and safe when properly prescribed and administered, but a remote risk of severe side effects exists. The problem of the risk/ benefit ratio stimulated the search for safer administration routes, including sublingual immunotherapy (SLIT), introduced in 1986. Currently SLIT is considered a viable alternative to SCIT1,2 and is supported by many clinical trials.2 The favorable safety profile (no severe adverse event in more than 15 years) was confirmed in several postmarketing surveillance studies.3,4 SLIT is convenient for the patient (no need for visits and injections), and a simplified administration schedule (short updosing and once-daily administration) would make it even more user-friendly. These characteristics would suggest a potentially good compliance. Compliance is defined as the degree to which the patient’s behavior coincides with the medical prescription 5 and is a common problem with all medications taken by the patient without a direct medical supervision.6 To date, there are very few data concerning the compliance with SLIT in the clinical trials. Thus, we designed a study (EASY: Evaluation of A novel SLIT formulation during a Year) to measure the compliance in a real-life setting. This survey, limited to the compliance aspect, was designed as multicenter and observational. It was conducted with SLIT prepared in plastic monodose containers to be taken once daily (SLITone; ALK-Abello´ , Lainate, Milan, Italy).