Lilly and Incyte recently announced results from their fourth Phase III study (RA-BEAM) on baricitinib in patients with active rheumatoid arthritis (RA). Historically, these clinical trials passed through several stages, which started as first Phase III trials in December 2014 (RA-BEACON), followed by second Phase III in February 2015 (RA-BUILD), then third Phase III (RA-BEGIN), and fourth Phase III (RA-BEAM) during 2015.
Rheumatoid arthritis is a disease identified by inflammation of the connective tissue that leads to progressive destruction of the joints, with researchers believing RA is induced by an autoimmune process of the body. Worldwide, over 23 million individuals live with RA, which results in about 50,000 deaths per year. Signs and symptoms of RA may include joints/back/muscle pain, swelling, fatigue, and low red blood cells (anemia).
There is no cure for RA, but the disease can be managed by various medications based on modifying agents like methotrexate and anti-inflammatory agents such as adalimumab. These medications have variable efficacies, and side effects that include joint damage and infections. For full efficacy, currently commercialized drugs are recommended to be injected intravenously. In contrast, baricitinib could be administrated orally once a day.
The purpose of RA-BEAM was to evaluate the efficacy and safety of baricitinib in patients with RA who showed little improvement with other drugs, like methotrexate for 24 weeks or adalimumab for 52 weeks. In RA-BEAM Phase III study, over 1,300 patients were enrolled and divided into three main groups treated with: 1) 4 mg oral once-daily baricitinib on background methotrexate, 2) 40 mg injectable every-other-week adalimumab on background methotrexate, and 3) placebo on background methotrexate.
The results suggested that after 12 weeks of treatment, patients achieved at least 20% improvement when compared to placebo and current injectable drug adalimumab. After 24 weeks, baricitinib was shown to prevent progressive radiographic structural joint damage in the patients. Furthermore, superior benefits of baricitinib in patients with RA were maintained at 12, 24 and 52 weeks of treatment.
With respect to side effects, similar serious infection rates were observed cross the groups. One case of tuberculosis was recorded in both groups of baricitinib and adalimumab, but no cases of gastrointestinal perforations were observed thus far. In the baricitinib group, nasopharyngitis and bronchitis were the most common observed events. When the treatment was discontinued due to side effects, the results were similar across all treatment groups.
In conclusion, these findings highlighted the superior activity of baricitinib in improving the signs and symptoms of patients with RA up to 52 weeks. When compared to standard injectable drugs, baricitinib could be administrated orally. “Combined results of these four Phase 3 studies give us confidence that, if approved, baricitinib could represent a valuable new treatment option for patients with RA,” said Rich Levy, MD, chief drug development officer, Incyte Corporation.