Ruxolitinib cream, a potential treatment option for vitiligo patients

USA: Treatment with Incyte's ruxolitinib cream in vitiligo patients significantly improved total-body repigmentation at week 52, according to recent data presented at the European Academy of Dermatology and Venereology Congress. Ruxolitinib cream is a nonsteroidal, anti-inflammatory, JAK inhibitor therapy.

The improvement in total-body repigmentation was assessed by a 50% or more improvement from baseline in the total vitiligo area severity index. This was a phase 2 study that was built upon previous data.

According to Mayo Clinic, vitiligo is a disease that causes the loss of skin colour in blotches. The extent and rate of colour loss from vitiligo are unpredictable. It can affect the skin on any part of the body. It may also affect the hair and the inside of the mouth.

The colour of the skin and hair is normally determined by melanin. In this skin disease, the cells that produce melanin die or stop functioning. It affects people of all skin types but is more noticeable in people having darker skin.

The first part of the study enrolled 157 adults with vitiligo and with depigmented areas of at least 0.5% of body surface area (BSA) on the face and at least 3% of the total BSA on nonfacial areas. Patients were randomly assigned across five treatment arms: ruxolitinib cream 1.5%, 0.5% or 0.15% administered once daily, ruxolitinib cream 1.5% administered twice daily or a nonmedicated vehicle control cream for 24 weeks, according to a press release from Incyte.

The second part of the study included patients enrolled in the first phase and occurred for an additional 28 weeks, for a total of 52 weeks. Patients receiving vehicle control or those who achieved less than 25% improvement in facial vitiligo area severity index (F-VASI25) at week 24 on ruxolitinib cream 0.15% were re-randomized to ruxolitinib cream 1.5% twice daily, 1.5% once daily or 0.5% once daily.

"We are very encouraged about the positive updated data presented at EADV, which demonstrate substantial facial and total body repigmentation of vitiligo lesions in patients treated with ruxolitinib cream, and continued improvements with longer duration of treatment," said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte said in the company's press release.

"As we seek to offer a much-needed option for those patients impacted by this life-altering disease, we are excited that the pivotal Phase 3 studies evaluating ruxolitinib cream in patients with vitiligo are underway, with results expected in 2021."

Key findings include:

• After 52 weeks of treatment with ruxolitinib cream 1.5% administered twice daily, 58% of patients achieved F-VASI50 and 51% of patients achieved F-VASI75.


• From week 24 to 52, the longer duration of therapy was associated with greater repigmentation assessed via VASI, according to the release.


• At week 24, 45.5% of patients receiving 1.5% ruxolitinib cream twice daily achieved F-VASI50 compared with 57.6% of patients at week 52.


• From baseline to week 52, F-VASI75 and F-VASI90 were achieved by 51.5% and 33.3% of patients treated with 1.5% ruxolitinib cream twice daily vs. 30% and 12% of patients at week 24, respectively.

"Many patients with vitiligo seek treatments that can repigment vitiligo lesions but, unfortunately, current therapeutic options are limited by poor efficacy, burdensome treatment regimens or side-effects," said Amit Pandya, M.D., Clinical Professor at the University of Texas Southwestern Medical Center. "The updated results from this study are encouraging as they demonstrate ruxolitinib cream's potential to become an effective treatment option for individuals with vitiligo."

Ruxolitinib cream is a proprietary formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild to moderate atopic dermatitis (TRuE-AD) with initial results expected in the first half of 2020, and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.