6:03AM Eli Lilly and Incyte (INCY) announce Baricitinib efficacy and safety data from the open-label, long-term extension of the Phase 2b JADA study in patients with Rheumatoid Arthritis; clinical improvements observed at week 24 were sustained at the end of 52 weeks (LLY) 51.78 : Co announced 52-week efficacy and safety data from the open-label, long-term extension of the Phase 2b JADA study of baricitinib in patients with active rheumatoid arthritis. Baricitinib, formerly LY3009104, is an orally available Janus kinase inhibitor being studied for use in the treatment of certain autoimmune conditions, including RA. Among patients completing the open-label extension, clinical improvements observed at week 24 were sustained at the end of 52 weeks. The long-term extension of the JADA study evaluated the efficacy and safety of baricitinib in 201 patients taking either 4 mg (n=108) or 8 mg (n=93) once daily for up to 52 weeks. Doses could be escalated to 8 mg once daily at 28 or 32 weeks at the investigator's discretion when the patient presented more than six tender and swollen joints.
Safety signals observed during the open-label extension were consistent with previously reported results of baricitinib. Among patients who remained on the 4 mg dose, treatment-emergent adverse events occurred in 57 (53 percent); serious adverse events (SAEs) in 11 (10 percent); infections in 34 (31 percent); and serious infections in four (4 percent).
This randomized, open-label, long-term extension of Phase 2b JADA study included 201 (95 percent) of the eligible 212 patients. Of the 201 patients, 184 completed 52 weeks of treatment, 15 discontinued treatment, and two patients had not yet completed the full 52 weeks of treatment. Patients received either 4 mg or 8 mg once-daily doses of baricitinib beginning at week 24 through week 52.
