AbbVie announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46% of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.0019). GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries.

GCA generally impacts elderly patients older than 50 years, most commonly between the ages of 70 and 80 years. Women have the high risk of developing this disease, which can cause headache, jaw pain and changes in or loss of vision, including sudden and permanent loss of vision. Key secondary endpoints were also met, including a higher percentage of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remissionb from week 12 through week 52 compared to patients receiving placebo in combination with a 52-week steroid taper regimen (37% versus 16%; pAbout SELECT-GCA SELECT-GCA (M16-852) was a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA.

The study consists of two periods. The first period, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients.

The second period will evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period. Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries. GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision.

It is the most common vasculitis affecting adults in western countries. Caucasian women over the age of 50 ? most commonly between the ages of 70 and 80 years ?

have the high risk of developing giant cell arteritis. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease. Upadacitinib (RINVOQ®): Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.6,7 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. RINVOQ (upadacitinib) U.S. Uses and Important Safety Information: RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.