Rheumatoid Arthritis Drug Shows Improvements Over Methotrexate and Humira

Two phase 3 trials of baricitinib showed statistically significant improvements in quality of life (QoL) symptoms and physical function in patients with rheumatoid arthritis (RA) compared with methotrexate or adalimumab (Humira).

Both trials demonstrated improvements in pain, fatigue, morning joint stiffness, and physical function as early as 1 week after starting treatment with baricitinib. The phase 3 trial RA-BEGIN showed that 81% of patients who received baricitinib monotherapy and 70% who received baricitinib plus methotrexate saw clinically meaningful improvements in physical function after 24 weeks compared with 70% of patients who received methotrexate along (p<0.05).

Clinically meaningful improvement in both trials were defined in the study as an improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score of ≥0.22. At 52 weeks, 68% of patients in the baricitinib monotherapy arm and 72% in the baricitinib in combination with methotrexate arm saw clinical meaningful improvements in physical function compared with 57% of patients treated with methotrexate alone (p<0.05).

Baricitinib alone or in combination with methotrexate was associated with significant improvements in pain, and clinically meaningful improvements in fatigue and the physical health components of the QoL assessment at 24 and 52 weeks compared with methotrexate used alone.

The phase 3 trial RA-BEAM required all patients to receive background methotrexate therapy. In patients treated with baricitinib, 75% reported clinically meaningful improvements in physical function at 12 weeks compared with 71% taking Humira (p=0.302).

At 24 weeks, researchers reported that 73% of patients treated with baricitinib monotherapy achieved clinically meaningful improvements in physical function compared with 64% of patients on Humira (p<0.05).

At 52 weeks, 68% of patients treated with baricitinib had clinical meaningful improvements in physical function compared with 58% of patients who took Humira (p<0.01). Furthermore, there was also an association found between baricitinib and significant improvements in pain, as well as clinically meaningful improvements in fatigue and physical health components of QoL compared to Humira.

“Our extensive phase 3 clinical trial program demonstrates that baricitinib could, if approved, offer a potentially significant improvement in the treatment of rheumatoid arthritis,” said Terence Rooney, MD, medical director of rheumatoid arthritis at Lilly Bio-Medicines. “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.”

There were no increases in adverse events leading to discontinuation, malignancies, or serious infections for baricitinib versus placebo or active comparators during the controlled periods of the program.

“Left untreated or uncontrolled, rheumatoid arthritis can dramatically impact patients' quality of life,” said Steven Stein, MD, chief medical officer, Incyte Corporation. “Patients and physicians alike deserve better treatment options beyond today's standard of care. If approved, baricitinib has the potential to become an oral drug option that may improve the clinical symptoms of the disease, as well as patients' ability to perform daily activities at home and at work.”