Phase III study of LY 3009104 (baricitinib) shows improvement in outcomes for rheumatoid arthritis- Eli Lilly and Incyte Corp

Eli Lilly and Incyte Corporation announced that new data from RA-BEACON � a pivotal phase III study of LY 3009104 (baricitinib) in the treatment of moderate-to-severe rheumatoid arthritis (RA) � showed baricitinib demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo. The results of the study were published in Annals of the Rheumatic Diseases.

The RA-BEACON study included patients who had insufficient response or intolerance to previous treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), including tumor necrosis factor (TNF) inhibitors. In these patients, treatment with baricitinib through 24 weeks significantly improved most patient-reported outcomes compared with placebo, and patients receiving baricitinib 4 mg showed the most rapid and greatest change. Previously, baricitinib has also shown significant clinical efficacy in these patients.

HRQOL was assessed using the 36-Item Short Form Health Survey (SF-36), a patient-reported instrument that collects information in multiple domains, including physical function, bodily pain, general health, limitation in role, vitality and social functioning. The SF-36 reports physical and mental component scores. Results of the study showed that at week 12, a clinically important improvement (at least 5) in the physical component score was achieved by 49 percent of patients taking baricitinib 2 mg; 53 percent of patients taking baricitinib 4 mg; and 32 percent of patients in the placebo group. At week 24, a clinically important improvement (at least 5) in the physical component score was achieved by 39 percent of patients taking baricitinib 2mg; 45 percent of patients taking baricitinib 4 mg; and 21 percent of patients in the placebo group.

Both doses of baricitinib (2 mg and 4 mg) also significantly improved fatigue as early as week 4 compared to placebo, and the greater improvement compared to placebo was maintained throughout the study. In RA-BEACON, through 24 weeks, 77 percent of patients on baricitinib 4 mg and 71 percent of patients on baricitinib 2 mg experienced treatment-emergent adverse events (AEs), compared to 64 percent of patients in the placebo group.

Comment: Baricitinib is an orally administered selective JAK1 and JAK2 inhibitor that spares JAK3. Unlike the injected TNF blockers, baricitinib, is an oral JAK inhibitor designed to block inflammatory signaling and treat the underlying cause of immune diseases including RA, all without the need for needles.

See- "Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)"- Josef S Smolen, Joel M Kremer, Carol L Gaich, Amy M DeLozier, Douglas E Schlichting, Li Xie, Ivaylo Stoykov, Terence Rooney, Paul Bird, Juan Miguel S�nchez Burs�n, Mark C Genovese, Bernard Combe Ann Rheum Dis annrheumdis-2016-209821 Published Online First: 31 October 2016 doi:10.1136/annrheumdis-2016-209821