The Italian Medicines Agency (Aifa) has granted reimbursement for Opzelura* (ruxolitinib) cream 15mg/g, the first and only specific treatment for non-segmental vitiligo affecting the face, the most widespread form, in adults and adolescents starting from 12 years of age. This was announced in a note by Incyte, a global biopharmaceutical company that developed the product, specifying that the medicine is subject to a limited medical prescription, to be renewed from time to time, and can be sold to the public on prescription from hospital centers or dermatological specialists.
Very visible due to the characteristic white spots, but little known and often reduced to a simple aesthetic problem, vitiligo is a chronic autoimmune disease that affects between 0.5% and 2% of the world population and which has a strong impact from a social, psychological and emotional point of view. Opzelura is the first and only drug that acts on the mechanism underlying the disease, allowing the repigmentation of the skin. “Finally, people affected by vitiligo will have a choice – says Ugo Viora, president of Anap Onlus, the national association of Friends for the Skin – Until now, the lack of effective treatments for this pathology has been one of the most impactful aspects on the psychological sphere of patients: not having a prospect of treatment and witnessing the progressive failure of tried-and-tested approaches leads patients to experience a sense of frustration and defeat. It is no coincidence that anxiety and depression are respectively 72% and 32% more common in affected people from vitiligo compared to the rest of the population. The arrival of a first specific treatment for vitiligo will change the perspective of thousands of patients and their families.”
Ruxolitinib is part of a class of Janus kinase inhibitors, also known as Jak inhibitors. Already used successfully in oncology and in various dermatological diseases, they represent an important innovation compared to the remedies used to date for vitiligo – we read in the note – because they act specifically on the pathogenetic mechanism underlying the disease, allowing to start the repigmentation process.
“The supporting data show that ruxolitinib has the potential to make a difference in the lives of people living with this condition – explains Giuseppe Argenziano, president of the Italian Society of Dermatology and Sexually Transmitted Diseases (Sidemast) – The results of the phase clinical trials 3 (True-V1 and True-V2) have in fact demonstrated the effectiveness of the drug in bringing a significant improvement in the repigmentation of both facial and body lesions in adults and adolescents from 12 years of age to date – remember – they were topical corticosteroids or calcineurin inhibitors, which however do not produce satisfactory results and have limitations due to adverse events. The arrival of ruxolitinib completely revolutionizes the scenario, offering patients an important and lasting clinical benefit, with a positive impact on quality of life”.
In Italy there are approximately 330 thousand people affected by vitiligo, a chronic autoimmune disease which, as such, is often associated with other problems such as thyroid diseases, chronic inflammatory bowel diseases, diabetes mellitus and alopecia areata. This characteristic, together with the complex pathogenesis and unpredictable progression, make vitiligo a challenging pathology to treat for the specialist. For Angelo Valerio Marzano, director of Dermatology Fondazione Irccs Ca’ Granda Ospedale Maggiore Policlinico di Milano and member of the Sidemast board, “the arrival of ruxolitinib is a change that will make the alliance between doctor and patient even more important. Many of the patients with vitiligo In fact, they could be demotivated by the previous failure of numerous therapeutic approaches. The average patient – he specifies – tries up to 6 without obtaining satisfactory results. The role of the specialist will therefore be fundamental in understanding the innovation behind ruxolitinib and l “importance of therapeutic adherence to maximize the effectiveness of the drug”.
“We are proud that the fruit of Incyte research can contribute to providing a significant response to all patients who, before today, did not have an effective solution to manage vitiligo – declares Onofrio Mastandrea, vice president and general manager of Incyte Italia – our commitment focuses on pathologies that are difficult to treat, with the aim of opening new paths to discover first generation treatments. Ruxolitinib is a concrete example and inaugurates our presence in dermatology, an area that will see us as protagonists in the future, with important innovations also expected. on the atopic dermatitis and hidradenitis suppurativa front. Incyte’s constant commitment to research – in Italy the company invests over 80% of its revenue in R&D – translates into a solid and promising pipeline, which will drive our growth. future”.
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