AbbVie, a global research-based biopharmaceutical company, announces that the Italian Medicines Agency (AIFA) has approved the reimbursement in Italy of upadacitinib 45 mg (induction dose) and 15 and 30 mg (maintenance doses) as the first Jak inhibitor for the treatment of adult patients with moderate to severe active Crohn’s disease who have had an inadequate response, lost response, or are intolerant to conventional therapy or a biologic agent.
“Today it is estimated that around 250 thousand people live in Italy suffering from chronic intestinal inflammatory diseases, including Crohn’s disease. This number is destined to increase significantly in the years to come”, says Flavio Caprioli, gastroenterologist at the Irccs Ca Foundation ‘Granda Ospedale Maggiore Policlinico in Milan and associate professor of gastroenterology at the University of Milan. These are immune-mediated pathologies that “have a very significant impact on the quality of life of patients – he underlines – also due to their onset at a young age, or in the midst of social life and at the beginning of the individual’s working life. We welcome the obtaining of reimbursement for upadacitinib by Aifa, a drug that is taken orally once a day and which, thanks to a unique mechanism of action, offers a new therapeutic option for a large number of patients, achieving objectives potentially able to change the course of Crohn’s disease.”
The European Commission – recalls a note – had approved upadacitinib in April 2023 thanks to the results of two induction clinical studies, U-Exceed and U-Excel, and a maintenance study, U-Endure.1. Clinical studies have shown positive results in endoscopic response, achieving clinical remission and healing of the intestinal mucosa.
“Upadacitinib is a therapy characterized by a new mechanism of action in Crohn’s disease – highlights Alessandro Armuzzi, head of the Chronic Intestinal Inflammatory Diseases Operational Unit of the Irccs Humanitas Clinical Institute – It acts by blocking the action of some substances involved in inflammatory processes and, in addition to having been shown to act effectively on the symptoms of the disease, it is able to reduce lesions to the digestive canal, to the point of achieving in many cases a real healing of the mucosa, with important benefits for patients as well as with possible impacts also in terms of long-term healthcare savings. Obtaining reimbursement represents a significant step forward in the clinical management of Crohn’s disease, considering that many patients, despite treatment with conventional or biological therapies, continue. to have an active disease”.
This is the sixth indication reimbursed by the National Health Service in Italy for upadacitinib, the note reports. In addition to Crohn’s disease, upadacitinib is reimbursed in Italy for the treatment of adult patients with ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis.
Crohn’s disease is a chronic and progressive systemic disease that manifests itself with inflammation of the gastrointestinal wall, causing persistent diarrhea and abdominal pain. It worsens over time in a substantial percentage of patients and can lead to complications that require urgent medical attention, including surgery. Because the signs and symptoms of Crohn’s disease are unpredictable, it takes a significant toll on the people who live with it, not only physically, but also emotionally and financially.
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