A Phase 2b Study of ABT-494, a Selective JAK1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti-TNF Therapy (original) (raw)

2016, Arthritis & rheumatology (Hoboken, N.J.)

To compare the efficacy and safety of ABT-494, a novel selective Janus kinase 1 inhibitor, with placebo, in patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response or intolerance to ≥1 anti-tumor necrosis factor (TNF) therapy. In this 12-week, double-blind, placebo-controlled, dose-ranging study, 276 patients with ≥1 prior anti-TNF therapy on a stable methotrexate dose were randomized equally to immediate-release ABT-494 3, 6, 12, or 18 mg twice daily or placebo. The primary endpoint was the proportion of patients achieving an ACR20 response at Week 12. At Week 12, significantly more patients in the ABT-494 groups (53-71%) versus placebo (34%) achieved an ACR20 response (NRI, P<0.05), with a dose-response relationship among all ABT-494 doses (P<0.001). ACR50/70 response rates were significantly higher in the ABT-494 groups (35-42% and 22-26%) versus placebo (ACR50, 16% and ACR70, 4%). Changes in DAS28(CRP) [ΔDAS28(CRP)] were significantly greater ...

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