HealthDay News — A novel selective JAK-1 inhibitor, ABT-494, is effective for rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX) or to at least 1 anti-tumor necrosis factor (anti-TNF) agent, according to 2 studies published online Nov. 28 in Arthritis & Rheumatology.
Mark C. Genovese, MD, from the Stanford University School of Medicine in Palo Alto, California, and colleagues examined the safety and efficacy of ABT-494 in 300 patients with moderate-to-severe RA and an inadequate response to MTX.1 Participants were randomized to 12 weeks of immediate-release ABT-494 at 3, 6, 12, or 18 mg twice daily, 24 mg once daily, or placebo. The researchers found that the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (ACR20) at week 12 was higher with ABT-494 than placebo (62% to 80% vs 46%).
Joel M. Kremer, MD, from Albany Medical College in New York, and colleagues compared the efficacy and safety of ABT-494 with placebo in 276 patients with moderate-to-severe RA receiving a stable dose of MTX, with an inadequate response or intolerance to at least one anti-TNF agent.2 Patients were randomized to receive immediate-release ABT-494 at 3, 6, 12, or 18 mg twice daily or matching placebo. The researchers found that significantly more patients receiving ABT-494 achieved an ACR20 response (53% to 71%) versus placebo (34%).
“In patients with an inadequate response or intolerance to anti-TNF agents, ABT-494 added to MTX showed rapid, dose-dependent improvements in RA signs and symptoms, with safety and tolerability similar to those of other drugs of this class,” the authors wrote.
Several authors from both studies disclosed financial ties to pharmaceutical companies, including AbbVie, which manufactures ABT-494 and funded both studies.
- Genovese MC, Smolen JS, Weinblatt, ME, et al. 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 Rheumatol. 2016;68:2857–2866. doi:10.1002/art.39808
- Kremer JM, Emery P, Camp HS, et al. A phase IIb study of ABT-494, a selective JAK-1 Inhibitor, in patients with rheumatoid arthritis and an inadequate response to anti–tumor necrosis factor therapy. Arthritis Rheumatol. 2016;68:2867–2877. doi:10.1002/art.39801