Post-hoc analysis shows pain improvement was consistent regardless of a patient's baseline pain severity.
Eli Lilly and Incyte Corporation have 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 was presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, California.
"While there are many treatments available for RA patients, these data suggest that baricitinib, if approved, may be an important advancement for patients suffering from RA-related pain," said James McGill, distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. "We are pleased to share these data suggesting that baricitinib could provide a potential new option for people living with RA. We remain committed to making life better for people with rheumatoid arthritis and improving patient care."
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, baricitinib 4 mg once daily or adalimumab 40 mg biweekly. 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%, ≥50% and ≥70% pain improvement, including the following results:
For patients whose baseline pain levels were higher than the median, treatment with baricitinib also led to faster pain improvements than adalimumab or placebo.
"Many RA patients continue to struggle with chronic pain," said Peter Taylor, presenting author and Professor at the University of Oxford. "These post-hoc analyses suggest that these RA patients may derive meaningful and consistent improvements in pain, particularly those patients with the highest pain at baseline."
The observed safety profile in RA-BEAM was consistent with previous trials evaluating baricitinib. The percentage of patients stopping therapy due to adverse events through Week 24 were 3% in placebo, 5% in baricitinib and 2% in the adalimumab group. Serious adverse event rates through 24 weeks were similar with placebo and baricitinib (5% each) and lower with adalimumab (2%). No additional safety signals were observed during the post-hoc analysis.
Lilly plans to resubmit the New Drug Application (NDA) with the FDA for baricitinib as a treatment for adult patients with RA before the end of January 2018. Baricitinib is approved for the treatment of adult patients with RA in several geographies, including the European Union and Japan.Read More
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