Lto vitiligo it is a chronic autoimmune disease, very visible due to the characteristics white spots on the skin, but little known and often debased as a simple problem of an aesthetic nature. Yet it is accompanied by other pathologies and, due to its strong social impact, makes the lives of patients difficult. This year World Vitiligo Day, which falls on June 25th, is accompanied by some good news: the approval of a new reimbursable drug offers truly encouraging prospects. The expert explains it.
Vitiligo: the numbers of the disease
It’s a pathology which affects between 0.5% and 25% of the world’s population with a strong impact from a social, psychological and emotional point of view. In Italy there are around 330 thousand people affected by this condition who, precisely due to its autoimmune nature, it is often associated with other problemslike the thyroid diseases, inflammatory bowel diseases, diabetes mellitus and alopecia areata. This characteristic, together with the unpredictable progression and the absence, to date, of specific treatments, makes vitiligo a challenging disease to treat.
A new drug repigments the skin
However, the research seems to have opened up a new perspective. Already in 2023 theEMA has approved, at European level, Ruxolitinib cream 1.5% in the treatment of vitiligo not segmental with facial involvement in adults and adolescents aged 12 and over of age. It is the first and only active ingredient that acts on the mechanism underlying the disease, allowing repigmentation of patients’ skin on both the face and body. The molecule is part of a class of Janus kinase inhibitors, also known as JAK inhibitors, already used successfully in oncology and various dermatological diseases.
The results of the studies
The results of the pivotal phase III clinical trials in more than 600 people with vitiligo non-segmental, starting from 12 years oldshowed the safety and efficacy of Ruxolitinib cream, compared to non-medicated cream, in significantly improve skin repigmentation. «The primary objective of the study was facial repigmentation of at least 75%, while the secondary objectives were facial repigmentation of at least 90% and body repigmentation of at least 50%, with patient satisfaction. 6 months after the start of therapy, these results were achieved by a significantly higher percentage in patients who applied the drug compared to those treated with the vehicle (non-medicated cream)”, explains the Professor Giuseppe Micali, Full Professor of Dermatology and Head of the Dermatology Clinic of the University of Catania and President of the last SIDeMaST Congress.
Vitiligo: new safe and reimbursable drug
«Furthermore, the repigmentation of the lesions continued until the end of the 52-week treatment period. Higher percentages on both the face and body in patients treated continuously. In particular, after 1 year of therapy three out of four patients treated with the drug had a repigmentation of at least 50% of facial lesions. One in two of at least 75%and one in three of at least 90%. Studies have also shown that Ruxolitinib cream is well tolerated by patients, presenting no adverse events related to the class of JAK inhibitors. The most common adverse event it is indeed an acne reaction at the application site of the treatment. Furthermore, on May 27th, L’AIFA approved its refundabilitynews that patients have been waiting for for a long time”, concludes Professor Micali.
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