RT Journal Article
SR Electronic
T1 Baricitinib dose reduction in patients with rheumatoid arthritis achieving sustained disease control: Final results from the RA-BEYOND study
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.2024-0906
DO 10.3899/jrheum.2024-0906
A1 Edwards, Christopher J.
A1 Krönke, Gerhard
A1 Avouac, Jérôme
A1 Li, Zhanguo
A1 Conti, Fabrizio
A1 Balsa, Alejandro
A1 Mo, Daojun
A1 Haladyj, Ewa
A1 Fischer, Peter
A1 Tanaka, Masaru
A1 Takita, Yasushi
A1 Hagimori, Kohei
A1 Takeuchi, Tsutomu
YR 2025
UL http://www.jrheum.org/content/early/2025/01/09/jrheum.2024-0906.abstract
AB Objective This study examines the impact of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4-mg once-daily up to 96-weeks.Methods Patients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patients who received baricitinib 4-mg for ≥15 months and maintained clinical disease activity index (CDAI) low disease activity (LDA) or remission (REM) were blindly randomized to continue 4-mg or taper to 2-mg. If needed, 2-mg treated patients could be rescued to 4-mg, and 4-mg treated patients could be rescued by adding or increasing conventional synthetic disease-modifying antirheumatic drugs. Efficacy and safety were assessed through 96-weeks. Non-responder imputation, considering rescued or discontinued patients as non-responders, was used for CDAI response analyses.Results At 96-weeks, most patients maintained LDA in both 2-mg and 4-mg arms, with a lower maintenance rate in 2-mg than 4-mg (NRI 59.9% and 70.2%, respectively). Patients maintained REM in 2-mg and 4-mg arms, 30.8% and 36.6% respectively. Rescue rates were 14.7% for baricitinib 4-mg and 22.5% for 2-mg. Of 112 patients who lost LDA in the 2-mg arm and rescued to 4-mg, 76.2% and 75.6% achieved LDA again at 12- and 24-weeks post-rescue.Conclusion In a randomized, blinded, phase 3 LTE study, maintenance of RA control following induction of sustained LDA/REM with baricitinib 4-mg was greater with continued 4-mg than after taper to 2-mg. Nonetheless, 76% of patients tapered to 2-mg could maintain LDA/REM or recapture with return to 4-mg if needed.