Phase III clinical trials of ABT 494 shows efficacy and safety at 48 weeks in rheumatoid arthritis

AbbVie announced new results from the Phase III clinical trials SELECT-EARLY and SELECT-COMPARE in patients with moderately to severely active rheumatoid arthritis showing that patients receiving ABT 494 (upadacitinib) once-daily (15 mg or 30 mg, SELECT-EARLY; 15 mg plus methotrexate (MTX), SELECT-COMPARE) through 48 weeks continue to demonstrate improved signs and symptoms of rheumatoid arthritis, as measured by ACR20/50, and clinical remission based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)less than 2.6.

Additionally, data from an integrated safety analysis across five Phase III SELECT clinical trials show that treatment with upadacitinib in patients with moderately to severely active rheumatoid arthritis demonstrates a consistent safety profile. The robust SELECT Phase III rheumatoid arthritis program evaluates more than 4,900 patients with moderately to severely active rheumatoid arthritis in six studies. These results are being presented at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.

Comment: Upadacitinib, an investigational oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in moderately to severely active rheumatoid arthritis and across multiple other immune-mediated inflammatory diseases.