AbbVie reports ‘positive’ results from Phase 3 SELECT-GCA study of upadacitinib

AbbVie announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib 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. 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 percent of patients receiving placebo in combination with a 52-week steroid taper regimen. 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. A lower percentage of patients experienced at least one disease flare through week 52 in the upadacitinib 15 mg group versus the placebo group. The study results also showed that upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.