Use of baricitinib for RA linked with significantly improved patient-reported outcomes

Compared to treatment with methotrexate or adalimumab, patients with rheumatoid arthritis experienced significant improvements in quality of life symptoms and other patient-reported outcomes when treated with baricitinib, according to a company press release on results from two phase 3 trials presented at the EULAR Annual Congress.

In the RA-BEGIN study, researchers randomly assigned 584 patients with rheumatoid arthritis (RA) to receive either once-weekly oral methotrexate monotherapy, 4 mg once-daily oral baricitinib monotherapy or 4 mg once-daily oral baricitinib in combination with once-weekly oral methotrexate. All patients had limited or no previous treatment with methotrexate and were naïve to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs), according to researchers. Similarly, researchers of the RA-BEAM study randomly assigned 1,305 patients who had active, moderate to severe RA to receive either placebo once-daily, 4 mg of baricitinib once-daily or 40 mg of adalimumab biweekly. All patients in this study received background methotrexate, according to a press release from Eli Lilly and Company and Incyte Corporation.

Results of the RA-BEGIN study showed baricitinib used as monotherapy or in combination with methotrexate was linked with a statistically significant improvement in physical quality of life measures vs. use of methotrexate alone. According to results of the RA-BEAM study, the baricitinib group had significant improvements in physical quality of life measures compared with patients in the adalimumab or placebo groups who had a previous inadequate response to methotrexate and were not treated with any biologic.

Both studies showed an increase in physical function and a decrease in pain and fatigue, according to the release, with all improvements in the baricitinib groups being statistically significant at week 24 and week 52 compared with either the methotrexate alone group or the adalimumab group, respective to the study.

“Our extensive phase 3 clinical trial program demonstrates that baricitinib could, if approved, offer a potentially significant improvement in the treatment of rheumatoid arthritis,” Terence Rooney, MD, medical director of rheumatoid arthritis at Lilly Bio-Medicines, said in the press release. “In these studies, baricitinib demonstrated superiority on a variety of efficacy measures compared to the leading biologic, adalimumab, as well as the current oral standard of care, methotrexate. Additionally, patients reported their personal experience with baricitinib, further highlighting its positive impact on patients’ daily lives and activities.”

References:

Keystone E, et al. Abstract #THU0609.

Schiff M, et al. Abstract #THU0623.

Smolen J, et al. Abstract #THU0166.

Smolen JS, et al. Abstract #THU0617. All presented at: EULAR Annual Congress; June 8-11, 2016; London.

Disclosure: Rooney is a shareholder and employee of Eli Lilly and Company.