Risankizumab is a selective, humanized immunoglobulin G1 (IgG1) monoclonal anti-body directed against interleukin (IL)-23 protein. The therapeutic indication of risankizumab is moderate-to-severe plaque psoriasis and psoriatic arthritis. The safety profile of risankizumab is currently defined by data obtained with clinical trials used for the authorization of entry into the market. The aim of this study was to expand information on the safety of risankizumab through a descriptive post-marketing analysis of real-world data regarding serious adverse reactions (SARs) to risankizumab found in the EudraVigilance database. The EudraVigilance database system, containing SARs linked to drugs not yet licensed for the market in the European Union (EU), was used. In EudraVigilance, SARs are described in single individual cases safety reports (ICSRs). More frequently reported serious SARs to risankizumab are associated with, in descending order, infections, cancer, nervous system disorders, cardiac disorders, abnormal laboratory results, pulmonary disorders, conditions aggravated, and skin disorders. Despite the classical limitations of this post-marketing study (lack of denominator, no certainty of causal relationship between the drug and the adverse reaction), analysis of real-world data related to SARs to risankizumab confirms the known safety profile of the drug but, at the same time, stimulates to further go into detail about the occurrence as adverse reactions of malignancies and their sex distribution.
Keywords: adverse reactions; anti-IL-23; gender; pharmacovigilance; psoriasis; risankizumab.