AbbVie Soothes Safety Fears With More Upadacitinib RA Data

With filings imminent for upadacitinib, AbbVie Inc. has announced positive results from a fifth late-stage trial assessing the investigational JAK1 inhibitor in rheumatoid arthritis (RA) which could help allay safety concerns regulators may have about the closely watched drug.

The US firm has presented top-line results which show that the SELECT-EARLY Phase III trial met the co-primary endpoints of patients achieving ACR50 (50% improvement in signs and symptoms of RA) at week 12 and clinical remission at week 24 with both doses of upadacitinib monotherapy (15 mg and 30 mg) compared with methotrexate (MTX). Specifically, 56% of patients in the once-daily 30 mg upadacitinib cohort achieved ACR50 compared with 28% for MTX. 66% of those on the 30 mg dose achieved clinical remission compared to 33% for MTX