AB0390 Safety and Efficacy of ABT-494, A Novel Selective JAK1 Inhibitor, in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance To Anti-TNF Biologic Therapy

BackgroundABT-494 is a novel selective JAK1 inhibitor.ObjectivesThe safety, efficacy, and dose response of ABT-494 were characterized vs placebo (PBO) in patients (pts) with moderately to severely active RA and an inadequate response to ≥1 anti-TNF biologic therapy (TNF-IR).MethodsThis was a phase 2b, 12-week, double-blind PBO-controlled study; TNF-IR pts receiving stable background methotrexate (MTX) were randomized 1:1:1:1:1 to ABT-494 3, 6, 12, and 18 mg twice daily (BID) or matching PBO. The primary efficacy endpoint was the proportion of pts who achieved an ACR20 response at week 12.ResultsAll 276 pts had failed ≥1 anti-TNF therapy prior to enrollment; 28% had received ≥2 anti-TNF biologics and 20% had also received non–anti-TNF biologics. Baseline (BL) characteristics were similar in all treatment groups. The proportion of pts achieving ACR20 at week 12 was significantly higher for all ABT-494 groups vs PBO (Table 1). There was a significant (P