Efficacy of baricitinib in patients with moderate to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Objective. To evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active RA who were either naive to DMARDs or who had inadequate response (IR) to MTX. Methods. Analyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naive) and RABEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naive patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4mg (+MTX) at week 24. Low disease activity (LDA) [Simple Disease Activity Index (SDAI) <= 11], clinical remission (SDAI <= 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI) <= 0.5] were assessed. Data were assessed using a non-responder imputation. Results. At week 148, SDAI LDA was achieved in up to 61% of DMARD-naive patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naive patients and 24% of MTX-IR patients; HAQ-DI <= 0.5 was reached in up to 48% of DMARD-naive patients and 38% of MTX-IR patients initially treated with baricitinib. Over 148 weeks, 3.6% and 10.7% of MTX-IR patients discontinued across treatment groups due to lack of efficacy or due to adverse events, respectively; discontinuation rates were similar in the DMARD-naive population. Conclusion. Treatment with baricitinib 4mg demonstrated efficacy for up to 3 years and was well tolerated.