The goal of this study is to give a current overview of both primary and secondary effectiveness measures of therapeutic treatments for clinical trials in patients with allergy rhinoconjunctivitis (ARC). This review, in particular, emphasizes parallels and variations in endpoints in studies using allergen immunotherapy (AIT), pharmacotherapy, and allergen avoidance, as well as future unmet needs in these areas. The European Academy of Allergy and Clinical Immunology (EAACI) suggested a standard for defining the primary endpoint for AIT studies in ARC in 2014, emphasizing the benefits and drawbacks, as well as unmet needs, when it came to outcome measurements for this therapy. Recently, the relative clinical impact (RCI) has been utilized to assess the percentage reduction of symptom ratings inactive vs placebo treatment as an (indirect) comparison of clinical efficacy of different treatments.
The United States has recommended many primary and secondary clinical goals of therapeutic treatments for clinical trials in ARC patients, such as AIT or medication. Furthermore, academic organizations such as the World Allergy Organization (WAO) and the European Academy of Allergy and Clinical Immunology have advocated for the inclusion of these outcomes in clinical studies (EAACI). However, a thorough international harmonization regarding the definition of clinical endpoints, the timing of clinical efficacy assessments, and the determination of the clinically meaningful and relevant magnitude of the efficacy of therapeutic interventions for clinical trials in ARC patients will be an urgent need in the future.
