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Baricitinib Superior to Adalimumab in RA Study
Positive results have been reported from a phase III study of baricitinib (Eli Lilly/Incyte Corporation), an investigational medication for patients with moderate-to-severe rheumatoid arthritis (RA).
The RA-BEAM trial evaluated the safety and efficacy of baricitinib in patients with active RA despite treatment with methotrexate, compared with placebo for 24 weeks or adalimumab (Humira, Abbvie) for 52 weeks. The study enrolled more than 1,300 patients who were randomly assigned to one of three treatment groups: 4 mg oral once-daily baricitinib on background methotrexate; 40 mg injectable every-other-week adalimumab on background methotrexate; or placebo on background methotrexate.
The trial met its primary objective of demonstrating superiority compared with placebo after 12 weeks of treatment based on the ACR20 response –– a standard clinical measure that represents at least a 20% improvement in RA disease activity. Baricitinib was also superior to adalimumab on key secondary objectives of ACR20 response and improvement in the DAS28-hsCRP score after 12 weeks of treatment. Following 24 weeks of therapy, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage. The treatment benefits with baricitinib observed at 12 and 24 weeks were maintained through 52 weeks of therapy.
Compared with placebo, serious adverse event rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across the the three treatmentgroups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. The rates of treatment-emergent adverse events, including infections, were higher for baricitinib and adalimumab compared with placebo. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis.
Baricitinib is a once-daily, oral, selective Janus kinase 1 (JAK1) and JAK2 inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of several inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of inflammatory conditions. Baricitinib demonstrated approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.
Source: Eli Lilly; October 14, 2015.