AbbVie Submits Applications for Rinvoq for Giant Cell Arteritis

AbbVie has submitted regulatory applications to both the FDA and the European Medicines Agency for Rinvoq (upadacitinib) to treat adult patients with giant cell arteritis (GCA)

Giant cell arteritis is an autoimmune disease that affects the large blood vessels that supply blood to the head and brain. It can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision. Inflammation associated with GCA can cause a narrowing of the blood vessels. Women over the age of 50 are more at risk, but men with GCA tend to suffer blinding.

Rinvoq is a JAK inhibitor that is approved for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and Crohn’s disease. It has a list price of $6,431.21 for a 30-day supply. Patient with commercial insurance may be eligible for a $0 copay card with a $14,000 limit per calendar year. The terms for the program indicate that AbbVie may discontinue co-pay support or reduce the annual limit to $4,000.00 if a plan includes a copay accumulate or maximizer program.

The applications for the giant cell arteritis indication are based on data from the SELECT-CGA phase 3 study, which enrolled 428 patients. The study showed that 46% of patients with giant cell arteritis (GCA) who were treated with Rinvoq with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared with 29 percent of patients who received placebo with a 52-week steroid taper regimen.

Key secondary endpoints were also met, including a higher percentage of patients achieved sustained complete remission from week 12 through week 52 compared with patients receiving placebo.

Rinvoq is also being studied in phase 3 clinical trials to treat patients with alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.