The Italian Medicines Agency (Aifa) has approved the reimbursement in Italy of Rinvoq * (upadacitinib, 15 mg), drug that can be taken once daily with and without methotrexate, for the treatment of adult patients with active psoriatic arthritis. This was announced by the research-based global biopharmaceutical company AbbVie, recalling that it is the first selective and reversible oral Jak inhibitor approved for three adult rheumatological indications in Europe: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, as well as having – in the dermatological field – the approved indication in atopic dermatitis.
“Psoriatic arthritis is an inflammatory arthritis, very heterogeneous in its clinical presentation, which mainly affects the skin and joints, characterized by joint inflammation, stiffness, fatigue and severe pain in a population still in the midst of their social and productive life “, says Carlo Salvarani, director of the rheumatology complex of the Irccs S. Maria Nuova hospital in Reggio Emilia. “We know from clinical studies that even today there is a part of patients who do not reach remission or the least activity of the disease, underlining the important need there is in this area. Doctors now have an important new treatment option available to help patients find relief from their debilitating symptoms, as well as ensure complete disease control and thus reduce disability. “
“The reimbursement of upadacitinib in Italy is an important step forward for both doctors and patients – underlines Roberto Gerli, president of the Italian Society of Rheumatology (Sir) -. It is about a drug administered orally once a day, of the category of selective Jak inhibitors, with great results in terms of efficacy and safety. As observed in clinical trials, upadacitinib has been shown to significantly improve the signs and symptoms of psoriatic arthritis, a disease that affects approximately 30% of patients with psoriasis. “
The European Commission – the AbbVie note recalls – had approved Rinvoq in January 2021 thanks to the results of the two clinical studies ‘Select-PsA 1’ and ‘Select-PsA 2’ registrations which demonstrated the efficacy and safety of upadacitinib on various disease parameters. “We welcome Aifa’s obtaining the reimbursement of upadacitinib – highlights Silvia Tonolo, president of the National Association of Rheumatic Patients (Anmar) – We hope that the various Italian regions will allow rapid access to this new treatment capable of improving the life of people affected by an often disabling pathology, capable of affecting the patient also from a psychological point of view “.
“The introduction of new therapies such as upadacitinib the quality of life of patients with chronic rheumatic diseases is changing for the bettermaking possible a return to normal life also thanks to the positive effect that these therapies have on pain “, says Antonella Celano, president of the National Association of People with Rheumatological and Rare Diseases.” Early diagnosis and effective therapies are to be considered a real investment as they allow people with psoriatic arthritis to continue their social and productive life, “he concludes.
Rinvoq – again reports the note – is indicated in the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who are intolerant to one or more disease-modifying antirheumatic drugs (Dmard). Could be administered alone or in combination with methotrexate. The recommended dose of upadacitinib is 15 mg once daily.
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