Ruxolitinib cream (Jakafi, Incyte) demonstrated positive results in 2 phase 3 studies investigating the topical for treatment of vitiligo in patients 12 years and older
Incyte announced positive results from its phase 3 studies investigating the efficacy and safety ruxolitinib cream (Jakafi; Incyte) for treatment of vitiligo in patients 12 years or older, according to a press release.1
Ruxolitinib is a topical Janus kinase (JAK) 1/2 inhibitor this is currently being evaluated for vitiligo and atopic dermatitis.
In the 2 phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), ruxolitinib cream met the primary endpoint of a proportion of patients achieving a greater than 75% improvement from baseline in the facial vitiligo area scoring index (F-VASI). Results demonstrated that patients treated with ruxolitinib cream 1.5% twice daily achieved F-VASI75 significantly more than patients treated with vehicle at week 24. Both studies also met the secondary endpoints.
Additionally, the safety profile for TRuE-V1 and TRuE-V2 was consistent with previously reported outcomes in phase 2 data, with no new safety signals being observed. The company plans on continuing the long-term safety and efficacy portions of the studies.
Incyte said data from the studies will be submitted for publication and presented at an upcoming scientific meeting during the second half of 2021.
“These positive results – the first phase 3 data to demonstrate significant improvements in facial and total body repigmentation – confirm the potential of ruxolitinib cream to be a meaningful treatment option for individuals living with and seeking treatment for their vitiligo,” said Jim Lee, MD, group vice president, inflammation & autoimmunity, Incyte, Wilmington, Delaware. “We look forward to working with regulators to bring this much needed treatment option to patients. If approved, ruxolitinib cream would be the first and only medical treatment for repigmentation in vitiligo.”
Incyte reported they plan to submit marketing applications for ruxolitinib cream for patients 12 years and older to the FDA and European Medicines Agency (EMA) in the second half of 2021. Currently, the FDA is reviewing the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis in patient 12 years and older.
“Vitiligo is a chronic immune-mediated skin condition that can significantly impact quality of life for those living with, and suffering from, this disease,” said David Rosmarin, MD, vice chair of research and education, dermatology Department at Tufts Medical Center, Boston, Massachusetts. “As a clinician, I am extremely encouraged by the initial findings from the TRuE-V program and the potential to have ruxolitinib cream as a future topical treatment option for vitiligo patients, who currently have limited therapies available that effectively and safely address repigmentation.”
1. Incyte announces positive results from phase 3 true-v program evaluating ruxolitinib cream in patients with vitiligo. Published May 17, 2021. Accessed May 17, 2021. https://www.businesswire.com/news/home/20210517005235/en/Incyte-Announces-Positive-Results-from-Phase-3-TRuE-V-Program-Evaluating-Ruxolitinib-Cream-in-Patients-with-Vitiligo