Positive top-line results from two phase 3 studies of upadacitinib (RINVOQ) in adult and adolescent patients with non-segmental vitiligo (NSV) have been announced by AbbVie.

NSV is the most common form of the chronic autoimmune disease vitiligo, occurring in more than 90% of vitiligo patients. It is characterised by symmetrical and bilateral white patches occurring on both sides of the body. 

Many people living with vitiligo suffer from self-consciousness, depression and anxiety, meaning that there is a high unmet medical need for new treatments.

Across both studies, upadacitinib achieved a >50% reduction in Total Vitiligo Area Scoring Index (T-VASI) score – which measures the extent of de-pigmentation across the body – and a >75% reduction in F-VASI, which measures the extent of de-pigmentation on the face. 

These results were measured at week 48 of the study and compared with placebo score. Both studies demonstrated statistically significant differences in key secondary endpoints in patients treated with upadacitinib versus placebo. 

No new safety signals for upadacitinib were observed, and the drug’s safety profile was seen to be consistent with its approved indications. However, upadacitinib has not yet been approved by regulatory authorities for treatment of NSV.

Kori Wallace, vice president, global head of immunology clinical development at AbbVie said: “Vitiligo is more than a skin condition – it's a chronic autoimmune disease that can deeply affect a person's confidence, identity and daily life. 

“There are no approved systemic medical therapies for achieving re-pigmentation in vitiligo.”