Baricitinib: Well-Tolerated, Effective Long-Term Treatment for Moderate to Severe Rheumatoid Arthritis

Hands Of Woman Deformed From Rheumatoid Arthritis holding pills
Hands Of Woman Deformed From Rheumatoid Arthritis holding pills
Study authors evaluated the long-term efficacy of once-daily baricitinib 4 mg in patients with active rheumatoid arthritis who were naïve to DMARDS, or who had inadequate response to MTX.

Once-daily 4 mg baricitinib was well-tolerated and effective for treating moderate-to-severe rheumatoid arthritis (RA) over a 3-year period, according to study findings published in Rheumatology.

The study was an analysis of pooled data from 2 completed 52-week phase 3 studies as well as an ongoing long-term extension study. In the RA-BEGIN study ( Identifier: NCT01711359), patients with no history of disease-modifying anti-rheumatoid drugs (DMARDs) use who were treated with either methotrexate-immediate release (MTX) or 4mg baricitinib plus MTX-IR were switched to open-label 4 mg baricitinib monotherapy at week 52.

In the RA-BEAM study ( Identifier: NCT01710358), patients originally received either once-daily baricitinib 4 mg, adalimumab subcutaneously every 2 weeks, or placebo while continuing MTX therapy. At week 24, patients having an inadequate response to MTX (MTX-IR) and placebo were switched to open-label 4 mg baricitinib; 4 mg baricitinib was also given to any treatment group at week 16 as a rescue therapy. Patients in the 2 studies were also switched to open-label 4 mg baricitinib monotherapy or 4 mg baricitinib with MTX in the long-term extension study.

The investigators assessed changes in low disease activity (LDA) using the Simple Disease Activity Index (SDAI) of 11 or less, clinical remission (SDAI ≤3.3), and physical functioning using the Health Assessment Questionnaire Disability Index (HAQ-DI) of 0.5 or less.

By week 148, SDAI LDA was achieved in approximately 61% of DMARD-naïve patients and 59% of MTX patients who initially received baricitinib. Additionally, SDAI remission was achieved in 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI of 0.5 or less was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients who initially received baricitinib.

Discontinuation of therapy reported in 3.6% of MTX-IR patients for lack of efficacy and 10.7% of MTX-IR patients for adverse events. Similar discontinuation rates were observed in the DMARD-naïve population.

A limitation of this study included the lack of long-term data comparisons between groups, which was due to insufficient statistical power for the analysis.

Based on these findings, this study suggests “baricitinib 4 mg may be considered for long-term treatment of early and refractory” RA, the study authors concluded.

Disclosure: This clinical trial was supported by Eli Lilly. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Smolen JS, Xie L, Jia B, et al. Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study. Rheumatology (Oxford). Published online November 17, 2020. doi:10.1093/rheumatology/keaa576