Baricitinib, a novel orally administered drug, appears effective in the management of rheumatoid arthritis (RA) according to study results presented this week in San Francisco at the annual American College of Rheumatology meetings.
Baricitnib belongs to a new class of drugs being evaluated in RA called JAK-1/2 inhibitors.
In one clinical trial that included 584 patients with RA who had received no more than three previous doses of methotrexate, and had no exposure to other disease-modifying anti-rheumatic drugs, a 20% improvement according to the criteria of the American College of Rheumatology (ACR20) was seen at week 24 in 77% of patients receiving baricitinib daily, and in 78% of those given baricitinib plus methotrexate compared to only 62% of those receiving methotrexate alone.
Responses to baricitinib were rapid, becoming apparent by week 1 in some patients, and no new safety concerns emerged in the study. Serious infections were reported in 0.6% and 1.9% of the baricitinib monotherapy and combination groups, and in 1.4% of the methotrexate group. Overall more patients in the combination and methotrexate groups than in the baricitinib monotherapy group discontinued because of adverse events.
A second study compared baricitinib to placebo or Humira (adalimumab) among 1,305 RA patients who had previously had an inadequate response to methotrexate. The ACR20 response at week 12 was 61% for individuals receiving Humira compared to 70% of those treated with baricitinib.
A once-daily orally administered drug that works quickly and has sustained benefit will represent an attractive treatment option for patients with RA.
References: Fleischmann R, et al. Baricitinib, Methotrexate, or baricitinib plus methotrexate in patients with early rheumatoid arthritis who had received limited or no treatment with disease modifying anti-rheumatic drugs: Phase III Trial Results. American College of Rheumatology 2015. Abstract 1045.
Taylor P, et al "Baricitinib versus placebo or adalimumab in patients with active rheumatoid arthritis and an inadequate response to background methotrexate therapy: results of a phase 3 study" ACR 2015; Abstract 2L.