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Baricitinib improved disease activity in patients not responding to conventional or biologic DMARDs.
Baricitinib improved disease activity in patients not responding to conventional or biologic DMARDs.
In patients with active rheumatoid arthritis (RA) symptoms that persisted despite taking methotrexate, treatment with baricitinib (Lilly/Incyte) led to "significant improvements," according to a data presented by researchers at the American College of Rheumatology Annual Meeting in San Francisco, CA.
Peter C. Taylor of the Kennedy Institute of Rheumatology at the University of Oxford and colleagues at other institutions reported baricitinib improved disease activity in patients who were not responding adequately to conventional synthetic DMARDs, or biologic DMARDs.
Researchers conducted a 24-week study of 1305 patients with RA who were randomized to receive either baricitinib, adalimumab (Humira/AbbVie), or placebo.
The findings showed the response rate for baricitinib was higher than placebo at week 12.
Compared with adalimumab, baricitinib was "superior with respect to measures including ACR20 response and improvement in DAS28-CRP at week 12," they noted.
Compared with placebo, daily diary measures of morning joint stiffness, duration and severity, fatigue, and worst joint pain were significantly improved in patients receiving baricitinib from as early as week 1.
However, 2 deaths occurred in the baricitinib treatment group, 1 from pneumonia and 1 from a bleeding duodenal ulcer.
Baricitinib is a selective JAK1 and JAK2 inhibitor. There are 4 known JAK enzymes: JAK1, JAK2, JAK3 and TYK2.
JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions.
The full trial results are in an abstract presented at the meeting.
FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a