Pooled analyses of eight Olumiant (baricitinib) clinical trials and long-term extension study in moderate-to-severe rheumatoid arthritis presented at EULAR.- Eli Lilly.

Eli Lilly and Company and Incyte Corporation announced a new pooled analysis of data from eight Olumiant (baricitinib) clinical trials, showing that baricitinib-treated and placebo-treated patients with moderate-to-severe rheumatoid arthritis (RA) had similar rates of serious infection incidents. Additionally, new data from the long-term extension (LTE) of Phase III trials showed that two years of baricitinib treatment significantly lowered the rate of joint damage progression and maintained an overall low disease activity (LDA) throughout the treatment period in these patients. These results were presented at an oral presentation and two poster presentations at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid.

Pooled infection data from 8 clinical trials- A pooled analysis of data from eight completed baricitinib clinical trials (four Phase III, three Phase II, one Phase 1) and one LTE study showed that there were similar incidence rates (IR) of severe infection events between the baricitinib and placebo groups. Specifically, during the first 24 weeks of treatment, in six trials, incidence rates of serious infections in the baricitinib (4 mg) and placebo groups were 3.8 and 4.2 per 100 patient-years (IR/100 PY), respectively. Additionally, the study also showed that in a set of four clinical trials, IRs of serious infections per 100 PY in the 2 mg and 4 mg groups were 4.2 and 5.7, respectively, compared to 5.1 in the placebo group in this set. The study also identified that concomitant corticosteroids use, prior biologics use, non-normal BMI, Asian region of enrollment, and advancing age are the key risk factors for serious infections.

Efficacy data from long-term extension study- Two presentations from a LTE study of baricitinib in moderate-to-severe RA patients showed the continued efficacy and long-term benefit with two years of treatment. Specifically, one of the analyses showed that at two years, progression of structural joint damage, measured by change in the van der Heijde modified total sharp score (mTSS), was significantly lower in patients treated with baricitinib throughout the two-year period compared to those who were first treated with placebo or methotrexate before switching to baricitinib. A second analysis of up to two years in a long-term extension study showed that among patients treated with baricitinib for up to three years, the proportion of patients with low disease activity (LDA) at 24 weeks in different treatment groups across trials remained similar or increased up to three years.

Additionally, the results also showed that most patients who had responded to treatment before entering the long-term extension study maintained their response throughout the two-year extension period. .

Comment: Baricitinib was approved in February 2017 for the treatment of adults with moderate-to-severe RA in the European Union and is marketed as Olumiant.