RA-BEAM trial showed baricitinibprovides greater pain control improvements than Humira or placebo for RA patients. Eli Lilly + IncyteCorporation.

Eli Lilly and Company and Incyte Corporation announced that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira (adalimumab) or placebo. A new post-hoc analysis of the Phase III RA-BEAM study disclosing outcomes of patient-reported levels of pain control will be presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, Calif.

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. This post-hoc analysis reviewed outcomes of patient-reported levels of pain control during the first 24 weeks of the trial as measured by a 0-100 mm visual analog scale (VAS) during each study visit. Analyses were not adjusted for multiplicity, were exploratory in nature and further research should be conducted to confirm these results. Analysis of reduction in pain included an assessment of the time required to achieve ?30 percent, ?50 percent and ?70 percent pain improvement, including the following results:1.Patients treated with baricitinib reported 30-percent pain improvement at a median 1.9 weeks post-baseline, compared to adalimumab at a median 2 weeks and placebo at a median 4.6 weeks. 2.Patients treated with baricitinib reported 50-percent pain improvement at a median four weeks post-baseline, compared to adalimumab at a median 7.9 weeks and placebo at a median 14 weeks. 3. Patients treated with baricitinib reported 70-percent pain improvement at a median 12.4 weeks post-baseline, compared to adalimumab at a median 20 weeks and placebo at a median of greater than 24 weeks. From Week 24, non-rescued patients in the placebo group were switched to receive baricitinib. 4. For patients whose baseline pain levels were higher than the median, treatment with baricitinib also led to faster pain improvements than adalimumab or placebo.