Longer-term use of Opzelura was well tolerated, with no serious treatment-related adverse events, according to a poster presented at the annual dermatology meeting.
Patients with vitiligo treated with Incyte’s Opzelura (ruxolitinib) largely improved or remained stable in their responses through week 52, according to a pooled analysis of two phase 3 studies. The results were presented during a poster presentation at the annual meeting of the American Academy of Dermatology Association in New Orleans, March 17 to March 20, 2023.
Vitiligo is a disease that causes the loss of skin color. Vitiligo occurs when cells that produce melanin die or stop functioning. Vitiligo affects people of all skin types, but it may be more noticeable in people with darker skin. The exact cause is unknown, but it is believed to be an autoimmune condition.
Worldwide prevalence estimates of vitiligo vary widely, ranging from 0.004% to 2.28%. One study suggests that about 40% of patients with vitiligo may be undiagnosed.
Incyte’s Opzelura is the first FDA-approved treatment for this condition and is the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. The approved approved it for this indication in June 2022. For patients over the age of 12. Over-activity of the JAK signaling pathway is believed to drive inflammation involved in vitiligo.
The approval was based on data from the pivotal phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the safety and efficacy of Opzelura versus vehicle in people with vitiligo at week 24. In the studies, treatment with Opzelura resulted in improvements in Vitiligo Area Severity Index (VASI) scores, which represent improvements in facial and total body repigmentation. At week 24, about 30% of patients treated with Opzelura achieved 75% or more improvement in the facial VASI, the primary endpoint, compared with a non-medicated cream in 8% of patients in the TRuE-V1 study and 13% of patients in the TRuE-V2 study.
Investigators, led by John E. Harris, M.D., Ph.D., associate professor in the department of Dermatology at the University of Massachusetts Chan Medical School, wanted to evaluate the changes in improvement or stability of facial vitiligo among patients who used Opzelura for 52 weeks.
At week 24, about 30% of patients treated with Opzelura achieved 75% or more improvement in the facial VASI, the primary endpoint, compared with a non-medicated cream in 8% of patients in the TRuE-V1 study and 13% of patients in the TRuE-V2 study. At week 52, about 50% of Opzelura-treated patients achieved 75% or more improvement. Additionally, at week 24, more than 15% of patients treated with Opzelura achieved 90% or more improvement in the facial VASI. At week 52, about 30% of Opzelura-treated patients achieved this improvement.
Opzelura was well-tolerated through 52 weeks of treatment. A total of 58.6% of patients experienced ≥1 treatment-emergent adverse event (AE), most commonly COVID-19 (7.3%), application site acne (6.5%), nasopharyngitis (5.8%), and application site pruritus (5.3%). Application site reactions were the most common treatment-related adverse events; these included acne (5.6%) and pruritus (4.7%), all of which were mild or moderate. No serious adverse events were considered related to treatment. There were no clinically significant changes in hemoglobin or platelet levels.
The study was funded by Incyte.