A project dedicated to Kawasaki disease, coordinated by the IRCCS Burlo Garofolo maternal and child health institute with the scientific contribution of the University of Trieste, has been awarded funding under the 2025 AIFA independent research call on rare diseases.

The study, funded with 983,000 euros, is one of 19 projects selected nationwide by the Italian Medicines Agency. Burlo will act as lead institution, with Prof. Andrea Taddio, Director of the Institute’s Paediatric Rheumatology and Clinical Immunology Unit and Associate Professor of Paediatrics at the University of Trieste.

The project aims to assess the use of anakinra, a biological drug targeting an inflammatory protein called IL-1, as a possible first-line treatment for Kawasaki disease. The approach is also innovative from a methodological point of view: the study will use control groups built from pre-existing clinical data, which will also be analysed through artificial intelligence tools.

Kawasaki disease is a rare inflammatory condition in children that affects blood vessels, particularly the coronary arteries, and can lead to cardiac complications. The standard treatment is intravenous immunoglobulin therapy, but a significant proportion of patients — around 20–25% — do not respond adequately, increasing the risk of severe clinical outcomes.

The aim of the study is therefore to generate new evidence on the efficacy of anakinra, while also assessing its safety, tolerability, impact on hospital stay and overall clinical outcomes.

“Receiving almost one million euros in funding is an important recognition of the scientific quality of the project and of the ability of the centres involved to work together on complex clinical challenges. The aim is to generate new scientific evidence that can translate into better treatment opportunities for children affected by this rare disease,” says Prof. Andrea Taddio, scientific coordinator of the project.

“Being included in the national AIFA ranking attests to the value of the clinical research developed by the network of professionals at our IRCCS and by the institutions collaborating within the Incipit Consortium. This result confirms the effectiveness of participatory research in generating innovation and new opportunities for patients,” says Anna Arbo, Director of the Hospital Pharmacy at Burlo.

The study was developed with the contribution of Prof. Gabriele Simonini, Director of the Paediatric Rheumatology Unit at the Meyer University Hospital IRCCS in Florence, and Prof. Marco Cattalini, Head of Paediatric Rheumatology at the ASST Spedali Civili di Brescia.