AbbVie submits vitiligo indication applications for Rinvoq

AbbVie has submitted applications to the FDA and EMA for new indications for upadacitinib (RINVOQ 15-mg) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV), according to a news release published today.

Vitiligo is a chronic, autoimmune disease characterized by the destruction of melanocytes, the cells responsible for skin pigment. As a result, white, depigmented patches form on the body. Although it is physically harmless, this disease can cause self-esteem issues as the white patches spread and therefore become more noticeable, especially on darker skin tones. Approximately one-third of vitiligo patients have reported symptoms of depression or anxiety as a result of their condition. 

Non-segmental vitiligo is the most common form of vitiligo, affecting approximately 84% of patients. Location of patches varies, but patients commonly report patches on the face, hands and groin. Global prevalence of vitiligo is approximately 0.5% to 1%.

The three primary treatment goals of treating vitiligo are disease stabilization, repigmentation, and maintaining repigmentation, but there are currently no approved systemic medications for achieving these treatment goals.

"Many patients experience ongoing frustration due to the unpredictability of non-segmental vitiligo spread and the lack of systemic treatment options that can stabilize disease progression and achieve skin re-pigmentation," Kori Wallace, M.D., Ph.D., vice president and global head of immunology clinical development, AbbVie, said in the news release. “The Viti-Up clinical studies explored these treatment gaps in vitiligo care and reinforced AbbVie's dedication to providing the first systemic treatment for patients, aiming to evolve the vitiligo treatment landscape."

Today’s submission was made using the results from two Viti-Up clinical studies, made up of two phases and involving 614 total participants. In Period A, patients were randomized to receive either 15-mg of upadacitinib or a placebo for 48 weeks. In Period B, a 112-week study, all patients received 15-mg of upadacitinib daily.

Effectiveness was measured using scores from Total Vitiligo Area Scoring Index (T-VASI) 50 and Facial Vitiligo Area Scoring Index (F-VASI) 75, in which there was at least a 50% and 75% reduction in symptoms from baseline at week 48, respectively. Approximately 70% of subjects had T-VASI > 10 at baseline, across both studies. By week 48, an average of 24% of participants given 15-mg of upadacitinib met both endpoints, compared with 12.8% given placebo.

Rinvoq is a JAK inhibitor that is currently prescribed to treat other autoimmune diseases in both adults and children. In adults, indications include active psoriatic arthritis, moderate to severe rheumatoid arthritis and moderate to severe Crohn’s disease. Indications for children and adults include moderate to severe eczema. It’s only approved for children who have active polyarticular juvenile idiopathic arthritis.

Possible side effects of Rinvoq include blood clots in the legs or lungs as well as allergic reactions such as hives and difficulty breathing.

It should be taken once daily with or without food and is available in 15 mg, 30 mg, and 45 mg extended-release tablets, as well as an oral solution, RinvoqLQ.

Upadacitinib is being studied in phase 3 trials as a treatment for alopecia areata, hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus.