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.
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