Safety and Efficacy of Baricitinib through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis

J Rheumatol. 2018 Jan;45(1):14-21. doi: 10.3899/jrheum.161161

This open-label extension (OLE) of a Phase 2b randomised controlled trial (RCT) found that safety data collected over 2 years of treatment were generally consistent with previous findings for baricitinib in RA.In the RCT, baricitinib demonstrated significant improvement in disease activity compared with placebo and an acceptable safety profile in patients with RA and an inadequate response to MTX. Patients who completed the 24-week double-blind period of the study were eligible for the OLE. Rates of AEs and laboratory abnormalities did not increase with prolonged treatment during the OLE. Important new event types such as opportunistic infections or malignancies did not emerge. Clinical improvement observed at Week 24 for a range of endpoints, including ACR20, ACR50, ACR70, DAS28-CRP, DAS28-ESR, CDAI, SDAI and HAQ-DI, was maintained or improved up to Week 128.These data support the potential utility of baricitinib as an additional therapy for the treatment of established RA.