Baricitinib, formerly LY3009104 (INCB28050), is an orally available Janus kinase (JAK) inhibitor being studied for use in the treatment of certain autoimmune conditions, including RA.
The randomized, open-label, long-term extension portion of the 52-week study evaluated the efficacy and safety of baricitinib in 201 patients taking either 4mg (n=108) or 8mg (n=93) once daily beginning at week 24 through week 52.
Doses could be escalated to 8mg once daily at 28 or 32 weeks at the investigator’s discretion when the patient presented with more than six tender and swollen joints.
As previously reported, in the initial 12-week portion of this study, baricitinib was associated with statistically significant improvements in the signs and symptoms of RA disease vs. placebo. These responses were maintained or improved during an additional 12 weeks of blinded treatment.
In the long-term extension portion, clinical improvements observed at week 24 were sustained through 52 weeks in RA patients.
The study is still ongoing, with all patients who are continuing in the study receiving baricitinib 4mg once daily.