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− Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1− The safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified1 − The clinical program reflects AbbVie's history of developing new treatment options for patients with immune-mediated diseases, where there remains significant unmet medical need
NORTH CHICAGO, Ill., April 18, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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 percent of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.0019).1
"Many people living with GCA continue to suffer from the potentially debilitating symptoms of this disease, with limited treatment options available to them," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "These results demonstrate our relentless commitment to improving the lives of people living with immune-mediated diseases by developing new treatments where significant medical needs still exist."
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 highest 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.2
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 percent versus 16 percent; p
