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Ruxolitinib cream improves repigmentation of vitiligo at 52 weeks

Among patients with vitiligo, treatment with ruxolitinib cream resulted in substantial improvements in total-body repigmentation at week 52 assessed by a 50% or more improvement from baseline in the total vitiligo area severity index, in a phase 2 study building upon previous data, according to data presented at European Academy of Dermatology and Venereology Congress.

“More than half of patients gained over half of the color back on their face who applied the cream twice daily at the highest concentration,” study researcher Amit Pandya, MD, clinical professor at the department of dermatology, University of Texas Southwestern Medical Center, told Healio Dermatology. “The cream is based on the newest research into what causes vitiligo, by specifically targeting the pathway which causes the immune attack in these patients.”

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.

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.

“That’s almost unheard of that you would get 90% of the color back on your face with just a cream,” Pandya said. “The exciting thing about these results is this cream was applied without any phototherapy, the light that patients received was simply during their normal activities.”

Pandya was also encouraged by the responses to treatment on the body. In patients with less than 20% BSA involvement, 45% achieved total-VASI45 (T-VASI45).

“The face tends to respond well to treatment, but below the neck is harder to treat,” he added. “It was encouraging to see that areas below the neck did improve.”

Additionally, an open-label extension is ongoing with patients receiving ruxolitinib cream 1.5% twice daily.

The phase 3 studies are underway with results expected in 2021, according to the Pandya. – by Abigail Sutton

Reference:

Harris JE, et al. Efficacy and safety of a 52-week, randomized, double-blind trial of ruxolitinib cream for the treatment of vitiligo. Presented at: 28th European Academy of Dermatology and Venereology Congress; Oct. 9-13, 2019; Madrid.

Disclosures: Pandya was a study investigator in this trial and is a consultant for Incyte and receives honoraria from the company.