Mite-Allergic Rhinitis: How to Evaluate Clinical Efficacy in Allergen-Specific Immunotherapy Trials?

Abstract

Opinion statement House dust mite (HDM) allergen exposure is the most important cause of perennial allergic rhinitis and/or asthma. Although allergen-specific immunotherapy (AIT) with HDM is well established, published studies have been characterized by substantial heterogeneity in clinical endpoints. Standardization in measuring clinical efficacy is required. Moreover, when designing an AIT trial with HDM allergens, several considerations have to be taken into account. The history of HDM allergy is less clear cut than the typical history of pollen allergy. In addition, clinical features of HDM allergy may differ from those of pollen allergy. Moreover, although not easily measurable, fluctuation in allergen exposure may cause variation in symptom severity and determine the timing of assessment of clinical effects of HDM AIT. Key points 1. A combined symptom and medication score (CSMS) is recommended as standard for the primary endpoint in future house dust mite (HDM) allergen-specific immunotherapy trials. 2. The diagnosis of HDM allergy is based on a carefully taken history in combination with sensitization to HDM allergens. 3. Eye symptoms are less prominent in patients with HDM-induced allergic rhinitis. Nasal symptoms, but not eye symptoms, should be included in the CSMS and in symptom scores as well. 4. As methods to determine allergen exposure vary and the efficacy of environmental control is a matter of debate, a practical approach consists of restraining patients from implementing HDM-reducing measures, such as removing carpets and introducing anti-mite covers, after the start of the study. 5. Efficacy evaluation in the period with the highest exposure to mites is recommended.