Baricitinib dose reduction in patients with rheumatoid arthritis achieving sustained disease control: Final results from the RA-BEYOND study.

Abstract

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.