The Italian Medicines Agency (Aifa) has approved the reimbursement in Italy of Renew* (upadacitinib, 15 mg) by AbbVieil first selective and reversible oral inhibitor of Jak available in our country which can be taken once daily to treat adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy. The company producing the drug announced it today in a note.
“Ankylosing spondylitis is a disease that it generally strikes at a young age, after the age of 25, and causes a progressive stiffening of the spine. It can cause severe pain, reduced mobility, and long-term structural damage. To date there is still a great therapeutic need, as a number of patients are unable to achieve complete control of the disease, with the therapies currently available “, says Roberto Gerli, president of the Italian Society of Rheumatology (SIR).
“In clinical studies, upadacitinib has been shown to rapidly improve multiple aspects of this disease – such as pain, inflammation and mobility – confirming a safety profile consistent with what has already been observed in the other therapeutic indications. Now Italian rheumatologists also have a new therapeutic option available to help patients find significant relief from their debilitating symptoms “, underlines Francesco Ciccia, professor of rheumatology, Luigi Vanvitelli University of Campania.
The European Commission – explains the note from the biopharmaceutical company – had approved Rinovoq in January 2021 thanks to the results of the studio clinico Select-Axis 1 which demonstrated the efficacy and safety of upadacitinib on several parameters of chronic inflammatory musculoskeletal disease which primarily affects the spine and is characterized by debilitating symptoms such as pain, limited mobility and structural damage. “The latest generation therapies are changing the lives of many patients but it is necessary to favor timely therapeutic interventions and early diagnosis with the aim of significantly improving people’s quality of life”, underlines Gian Domenico Sebastiani, elected president of the Italian Society of Rheumatology. .
Rinovoq is the first selective and reversible oral inhibitor of Jak reimbursed in Italy in three rheumatological indications: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. At European level, the drug has obtained approval from the European Medicines Agency (Ema) for the treatment of non-radiographic axial spondyloarthritis, atopic dermatitis and ulcerative colitis
“We welcome Aifa’s obtaining the reimbursement of upadacitinib for ankylosing spondylitis, and we hope that the various Italian regions will allow rapid access to this new treatment capable of improving the lives of people suffering from an often disabling disease. , capable of affecting the patient also from a psychological point of view ”, declares Silvia Tonolo, president of the National Association of Rheumatic Patients.