Researchers recently examined the effects of baricitinib dose reduction in patients with rheumatoid arthritis who achieved sustained disease control. The RA-BEYOND study, a long-term extension of previous phase III trials, provided significant insights into the efficacy and safety of tapering baricitinib from 4 mg to 2 mg daily.

The study involved 996 patients who had previously completed a phase III study and were rerandomized to either continue with 4 mg of baricitinib or taper to 2 mg after achieving sustained low disease activity (LDA) or remission (REM) for at least 15 months. The primary endpoints included the proportion of patients who maintained a Clinical Disease Activity Index score of up to 10, and the time to relapse after randomization.

At the 96-week mark, 59.9% of patients in the 2 mg group maintained LDA compared with 70.2% in the 4 mg group, while 30.8% and 36.6% maintained REM, respectively. Rescue rates were 14.7% for the 4 mg group and 22.5% for the 2 mg group. Among the 112 patients who lost LDA in the 2 mg arm and were rescued to 4 mg, 76.2% and 75.6% achieved LDA again at 12 and 24 weeks postrescue.

The investigators also explored baricitinib's safety profile. Treatment-emergent adverse events occurred at rates of 47.2 per 100 patient-years in the 4 mg group and 46.9 in the 2 mg group. Serious adverse events were reported at 9.6 per 100 patient-years in the 4 mg group compared with 7.3 in the 2 mg group, and serious infections occurred at rates of 3.2 and 1.6 per 100 patient-years, respectively, which indicated a statistically significant reduction in serious infections when tapering to 2 mg.

"Most patients maintained control of disease activity or regained it with return to 4 mg if needed," wrote Christopher J. Edwards, MD, of the Southampton Clinical Research Facility at University Hospital Southampton in the U.K., with colleagues.

"Dose tapering to 2 mg baricitinib after induction of sustained RA control with 4 mg appears reasonable. However, the decision to dose taper should be part of the shared decision-making process between the patient and physician, considering the balance between risk and benefit," the investigators concluded.

Full disclosures can be found in the study. 

Source: The Journal of Rheumatology