Allergen-specific immunotherapy and real-world evidence

Abstract

Allergen immunotherapy is the main method of IgE-dependent allergic diseases pathogenetic treatment which is widely used in the clinical practice. Despite the fact that there is a large amount of randomized placebo-controlled trials data on the allergen immunotherapy efficacy, a number of questions remain unanswered regarding the efficacy of the allergen immunotherapy in real practice. These questions can be answered using real-world evidence. Conducting real-world evidence studies of the allergen immunotherapy it is necessary to follow a strict methodology and to perform the multivariate analysis of the available data. Using of statistical methods reduces the risk of bias. The REACT study is currently the largest and most comprehensive real-world evidence study of the allergen immunotherapy, which included more than 90,000 patients with allergic rhinitis from Germany. The method of statistical adjustment a propensity score match was used to ensure comparable groups and representative obtained data. The REACT study provided results of fundamental clinical and public health significance: the allergen immunotherapy leads to a sustained and long-term medicine prescribing reduction in patients with allergic rhinitis and asthma, improved control of asthma, and also prevents development of exacerbations and respiratory infections in asthma patients. The REACT study is a good quality real-world evidence study with strict methodology and representative results. Further high quality standard studies of real-world data may not only confirm the randomized trials evidence, but also may become a source of new evidence for the allergen immunotherapy efficacy and safety in real clinical practice.