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

Journal article

Objective:

To evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active rheumatoid arthritis who were either naïve to DMARDs or who had inadequate response (IR) to methotrexate (MTX).

Methods:

Analyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naïve patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4 mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4 mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4 mg (+MTX) at week 24. Low disease activity (SDAI ≤11), clinical remission (SDAI ≤3.3), and physical functioning (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-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤0.5 was reached in up to 48% of DMARD-naïve 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-naïve population.

Conclusions:

Treatment with baricitinib 4 mg demonstrated efficacy for up to three years and was well-tolerated.

Authors: Smolen, JS; Xie, L; Jia, B; Taylor, PC; Burmester, G

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Oxford University Press
• Journal: Rheumatology
• Volume: 60
• Issue: 5
• Pages: 2256-2266
• Publication date: 2020-11-17
• Acceptance date: 2020-07-30
• DOI: 10.1093/rheumatology/keaa576
• EISSN: 1462-0332
• ISSN: 1462-0324
• Language: English
• Keywords: rheumatoid arthritis; clinical remission; baricitinib; low disease activity; long-term efficicacy; FFR