Detailed results demonstrate baricitinib superiority to adalimumab in improving signs and symptoms of RA

Patient-reported pain, joint stiffness, fatigue and physical function scores significantly improved with baricitinib compared to adalimumab.

Improvements in mean number of swollen and tender joints and a reduction in pain were seen as early as one week for baricitinib versus placebo. At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function. Patient-reported outcomes, including degree of tiredness and the severity and duration of morning joint stiffness, assessed daily for the first 12 weeks of the study, were all significantly improved with baricitinib compared to adalimumab.

At week 52, structural changes in the joints, as measured by changes in the modified Total Sharp Score, were significantly improved for both baricitinib and adalimumab compared with placebo. Lilly and Incyte previously announced that the study met its primary objective of demonstrating superiority for baricitinib versus placebo based on ACR20 response rate after 12 weeks of treatment.

"RA is a lifelong condition, but it can be managed with treatment to help control symptoms, including joint inflammation and fatigue, to slow the progression of the disease and improve a patient's quality of life," said Peter Taylor, study author and Norman Collisson chair of Musculoskeletal Sciences in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. "These findings suggest that the once-daily oral drug baricitinib, if approved, could provide another treatment option for those with insufficient response to current therapy."

RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.

"This is the first Phase III study showing that a once-daily, oral treatment significantly improved clinical outcomes compared with injectable adalimumab for patients with active RA who were also receiving treatment with methotrexate," said William Macias, distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. "Lilly is committed to improving outcomes for patients living with this chronic condition."

Serious adverse event rates were similar for baricitinib compared with placebo and lower for adalimumab, while serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported, in the adalimumab group. Four deaths occurred, one in the placebo arm, two in the baricitinib arm and one in the adalimumab arm. Two potential opportunistic infections occurred in the baricitinib arm; neither were considered serious. Temporary interruptions in treatment due to adverse events occurred with similar frequency across treatment groups.

"The positive results of the RA-BEAM trial reinforce the potential of baricitinib to quickly improve RA signs and symptoms, physical function and patient-reported outcomes, while inhibiting joint damage," said Rich Levy, chief drug development officer, Incyte Corporation. "If approved, this once-daily oral treatment may offer RA patients benefits above those seen with injectable adalimumab."