Abstract
Sublingual immunotherapy (SLIT) is an effective and well-tolerated method of treating allergic respiratory diseases associated with seasonal and perennial allergens. In contrast to the subcutaneous route, SLIT requires a much greater amount of antigen to achieve a clinical effect. Many studies have shown that SLIT involves a dose–response relationship, and therefore it is important to use a proven clinically effective dose from the onset of treatment, because low doses are ineffective and very high doses may increase the risk of side effects. A well-defined standardization of allergen content is also crucial to ensure consistent quality, potency and appropriate immunomodulatory action of the SLIT product. Several methods of measuring antigenicity are used by manufacturers of SLIT products, including the index of reactivity (IR), standardized quality tablet unit, and bioequivalent allergy unit. A large body of evidence has established the 300 IR dose of SLIT as offering optimal efficacy and tolerability for allergic rhinitis due to grass and birch pollen and HDM, and HDM-induced moderate, persistent allergic asthma. The 300 IR dose also offers consistency of dosing across a variety of different allergens, and is associated with higher rates of adherence and patient satisfaction. Studies in patients with grass pollen allergies showed that the 300 IR dose has a rapid onset of action, is effective in both adults and children in the short term and, when administered pre-coseasonally in the long term, and maintains the clinical benefit, even after cessation of treatment. In patients with HDM-associated AR and/or asthma, the 300 IR dose also demonstrated significant improvements in symptoms and quality of life, and significantly decreased use of symptomatic medication. The 300 IR dose is well tolerated, with adverse events generally being of mild or moderate severity, declining in frequency and severity over time and in the subsequent courses. We discuss herein the most important factors that affect the selection of the optimal dose of SLIT with natural allergens, and review the rationale and evidence supporting the use of the 300 IR dose.
Highlights
Allergic rhinitis (AR) is one of the most common chronic conditions worldwide, affecting an estimated 500 million people [1]
The recommended approach to the management of AR is a combination of patient education, symptomatic pharmacotherapy and allergen immunotherapy (AIT)
In studies of Sublingual immunotherapy (SLIT) that used adverse event (AE) as a clinical endpoint, dose-dependent increases in efficacy were not associated with an increased frequency of AEs, which possibly reflects the different sites of action within the immune system
Summary
Allergic rhinitis (AR) is one of the most common chronic conditions worldwide, affecting an estimated 500 million people [1]. An analysis of dose–response studies in AR has been conducted by the European Academy of Allergy and Clinical Immunology Immunotherapy Interest Group task force on dose effect This found that, for grass pollen, low doses of allergen (e.g. 5–7 μg Phl p 5 per day) are ineffective, and daily doses of 15–25 μg of the major allergen protein have been demonstrated for significant clinical improvement, as measured by symptom scores with a different administration protocol [11]. After 1 month of treatment, this improvement was significantly higher for the 300 IR dose versus placebo and was maintained over the following months [37] Taken together, these studies in patients with grass pollen-induced ARC demonstrate that the 300 IR dose has a rapid onset of action and is effective in both adults and children over the short term, and when administered discontinuously over the long term, and is associated with a prolonged benefit, even after cessation of treatment. Patients in the 300 IR group experienced a significant reduction in mean Average Adjusted Symptom Score (AAdSS), compared
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