NORTH CHICAGO, Ill., April 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study that evaluated the efficacy and safety of upadacitinib (RINVOQ®, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (DUPIXENT®, per its labeled dose) in adults and adolescents (?12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable.
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 (GCA).
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
Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval when the agency endorsed it in Crohn's disease. After a new positive pivotal trial, the drug could be bound for another label expansion.
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AbbVie has released long-term efficacy and safety data from three Phase III trials investigating Rinvoq (upadacitinib) in moderate-to-severe atopic dermatitis.