The European Commission (EC) has granted marketing authorization for ruxolitinib (Opzelura) cream 15 mg/g for treating nonsegmental vitiligo with facial involvement in people 12 years of age and older.
Ruxolitinib, a Janus kinase (JAK) inhibitor, is the first and only approved treatment in the European Union that supports repigmentation in eligible patients with nonsegmental vitiligo, a chronic autoimmune disease characterized by patchy loss of skin color from the progressive destruction of pigment-producing cells known as melanocytes.
Disease Can Affect Employment Options, Mental Health
Vitiligo not only affects physical health but also threatens quality of life. It can make employment more difficult and increase the risk of psychosocial health conditions, such as depression.
The EC decision follows the endorsement by the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year and covers all 27 European Union Member States, Iceland, Norway, and Liechtenstein.
Last year in July, ruxolitinib cream became the first repigmentation treatment approved by the US Food and Drug Administration (FDA) for nonsegmental vitiligo, the most common form of the disease.
The EC decision is based on data from two pivotal phase 3 trials (TRuE-V1 and TRuE-V2), assessing the efficacy and safety of ruxolitinib vs vehicle (non-medicated cream) in more than 600 people with nonsegmental vitiligo, age 12 and older.
Positive Results Evident at 6 Months
According to drugmaker Incyte, the study drug resulted in significant improvements in facial and total body repigmentation vs vehicle, which was demonstrated by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at week 24 vs vehicle and in an open-label extension at week 52.
In the trials, at week 24, researchers found that 29.8% and 30.9% of patients treated with ruxolitinib achieved at least 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared with 7.4% and 11.4% of patients in the vehicle groups, in TRuE-V1 and TRuE-V2, respectively.
“At Week 52, approximately one in two of [ruxolitinib]-treated patients achieved F-VASI75,” the company states in a press release. “Additionally, at Week 24, more than 15% of patients treated with [ruxolitinib] achieved ≥90% improvement from baseline in F-VASI (F-VASI90), compared to approximately 2% of patients treated with vehicle.”
At 1 year, approximately one third of ruxolitinib-treated patients achieved F-VASI90.
No Serious Side Effects
There were no serious treatment-related adverse events related to ruxolitinib cream. The most common adverse reaction was acne at the application site.
In patients with nonsegmental vitiligo with facial involvement, ruxolitinib cream is approved for topical use twice a day to depigmented areas up to a maximum of 10% body surface area.
The company notes that satisfactory repigmentation may take more than 6 months of treatment.
Overactivity of the JAK signaling pathway is thought to drive inflammation involved in the progression of vitiligo. In the EU, European Economic Area countries and United Kingdom diagnosed vitiligo prevalence is estimated to be about 1.5 million patients, according to the company, with approximately 80% living with nonsegmental vitiligo.
“Vitiligo is a chronic autoimmune disease that impacts many aspects of a person’s life,” Jean-Marie Meurant, vice-president of the Vitiligo International Patient Organizations Committee, said in the Incyte statement. “[N]ew treatment options are important for our community as it gives people with vitiligo something they have long been hoping for: the choice to treat their disease.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
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