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Baricitinib Superior to Adalimumab in RA Patients

Phase 3 trial meets primary endpoint

Positive results have been announced from the phase 3 RA-BEAM trial of baricitinib (Eli Lilly), an investigational medication for patients with moderate-to-severe rheumatoid arthritis (RA).

The study 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 (Humira, Abbvie) on the key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment. Following 24 weeks of treatment, 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.

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 a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than against JAK 3 in kinase assays.

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 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.

Compared with placebo, serious adverse events rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. 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. Discontinuations due to adverse events occurred with similar frequency across treatment groups. A majority of patients completing this trial opted to participate in a long-term extension study.

Source: Lilly, October 14, 2015

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