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Efficacy and Safety of ABT-494, a Selective JAK-1 Inhibitor, in a Phase IIb Study in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate ARTHRITIS & RHEUMATOLOGY Genovese, M. C., Smolen, J. S., Weinblatt, M. E., Burmester, G. R., Meerwein, S., Camp, H. S., Wang, L., Othman, A. A., Khan, N., Pangan, A. L., Jungerwirth, S. 2016; 68 (12): 2857-2866

Abstract

To evaluate the efficacy and safety of ABT-494, a selective JAK-1 inhibitor, in patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX).Three hundred RA patients receiving stable doses of MTX were randomly assigned equally to receive immediate-release ABT-494 at 3, 6, 12, or 18 mg twice daily, 24 mg once daily, or placebo for 12 weeks. The primary efficacy end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 12, as determined using the last observation carried forward method.At week 12, the proportion of ACR20 responses was higher with ABT-494 (62%, 68%, 80%, 64%, and 76% for the 3, 6, 12, 18, and 24 mg doses, respectively) than with placebo (46%) (using nonresponder imputation) (P?

View details for DOI 10.1002/art.39808

View details for Web of Science ID 000389153400006

View details for PubMedID 27390150

View details for PubMedCentralID PMC5132065