AbbVie announces that the Italian drug agency Aifa has approved the reimbursement in Italy of Rinvoq* (upadacitinib) for the treatment of adult patients with atopic dermatitis, the most common inflammatory skin disease. Upadacitinib demonstrated rapid and significant improvement in eczema and reduction in itching compared to placebo at or earlier week 16. The clinical benefits remain constant over time. This is the fourth reimbursed indication for upadacitinib in Italy.
“We welcome the reimbursement of upadacitinib by Aifa – says Mario Picozza, president of Andea, the National Association of Atopic Dermatitis – a treatment capable of modifying the course of atopic dermatitis. We also hope that all the Italian Regions will favor the most quickly possible access to this new treatment capable of improving the lives of people affected by an often disabling pathology, also capable of affecting psychological well-being and social relationships”.
Atopic dermatitis is a “very frequent chronic inflammatory skin disease – explains Francesco Cusano, president of Adoi, the Italian hospital dermatologists association – It manifests itself with redness and itching, often intense and sometimes uncontrollable, which can have a disruptive impact on the quality of life cause of very disabling symptoms. In recent years, research has made great progress, allowing for the development of more targeted, selective and effective therapeutic solutions such as upadacitinib. Doctors and patients need these innovative therapies to better treat and manage such a complex disease and multifactorial such as atopic dermatitis”. The recommended dose of upadacitinib in atopic dermatitis in adults is 15 or 30 mg once daily (based on patient characteristics), and 15 mg once daily for adults 65 years of age and older. Upadacitinib can be used with or without topical corticosteroids.
“As with other diseases, even for atopic dermatitis the dermatologist must adapt the treatment to the individual patient based on the severity of the clinical picture, the age of the patient and his general state of health – underlines Giuseppe Monfrecola, president of Sidemast, the Italian Society of medical, surgical, aesthetic dermatology and sexually transmitted diseases – The aim is to reduce the signs of the disease and the itching that strongly compromise the quality of life of patients.In Italy, a Janus kinase inhibitor is now available (it preferentially inhibits Jak1 and Jak1/3), called upadacitinib, which is taken once a day by mouth.”
“In clinical studies – adds Monfrecola – upadacitinib has been shown to act rapidly both on itching and on skin lesions, with a safety profile consistent with what has already been observed in other therapeutic indications. Furthermore, it has been observed that the clinical benefits remain constant over time also thanks to the fact that oral administration has obvious advantages in terms of adherence to therapy”.
The European Commission – recalls the note – had approved upadacitinib in September 2021 thanks to the results of one of the largest phase 3 development programs in atopic dermatitis, which involved more than 2,500 adults and adolescents with moderate to severe disease. The studies evaluated the efficacy and safety of upadacitinib as monotherapy and in combination with topical corticosteroids compared to placebo. Discovered and developed by AbbVie, upadacitinib is a selective and reversible Jak inhibitor currently being studied in several immune-mediated inflammatory diseases. In human cell samples, upadacitinib preferentially inhibits Jak1 or Jak1/3 signaling with functional selectivity over that of cytokine receptors via Jak2 pairs.
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