Eli Lilly and Incyte have announced the results of an analysis of 8 Olumiant (baricitinib) clinical trials, as well as data from a long-term extension (LTE) of Phase 3 trials evaluating the efficacy of baricitinib. These reports were presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
Four Phase 3 clinical trials of baricitinib in the treatment of moderate-to-severe active rheumatoid arthritis enrolled patients who were methotrexate-naïve or had inadequate response to methotrexate, conventional disease-modifying antirheumatic drugs (DMARDs) or DMARDs with TNF inhibitors.
Data drawn from eight clinical trials (four Phase 3, three Phase 2, one Phase 1, and one LTE) showed similar incidence rates (IR) of severe infection events between treatment and placebo groups. Treatment arms consisted of baricitinib 2mg or 4mg tablets. In 6 trials, the IR of serious infections per 100 patient-years (IR/100 PY) were 3.8 in baricitinib 4mg group vs. 4.2 in placebo. In a set of 4 trials, comparable IR/100 PY scores were seen in baricitinib 2mg (4.2), baricitinib 4mg (5.7), and placebo (5.1).
Additionally, the study recognized several key risk factors for serious infections, which included concomitant corticosteroids use, advancing age, non-normal BMI, Asian region of enrollment, and prior biologics use.
In terms of long-term benefit and efficacy, one analysis of the extended Phase 3 study showed that treatment with baricitinib for 2 years significantly slowed the progression of structural joint damage vs. placebo or methotrexate before switching to baricitinib. This was measured by the change in van der Heijde modified total sharp score (mTSS).
In another analysis of the LTE study, it was found that among patients treated with baricitinib for up to 3 years, rates of low disease activity (Simplified Disease Activity Index score ≤11) at Week 24 remained similar or increased up to three years, across different treatment groups. Patients who were treatment-responsive prior to the LTE study also maintained response throughout the 2-year extension period.
Olumiant is an oral Janus kinase (JAK) inhibitor; JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.
Baricitinib is not currently approved in the United States.