Baricitinib May Not Increase Infections in Rheumatoid Arthritis

The rates of serious infection incidents were similar in baricitinib-treated and placebo-treated patients with moderate-to-severe rheumatoid arthritis in a new pooled analysis of data from eight Olumiant® (baricitinib) clinical trials.

In addition, two years of baricitinib treatment significantly lowered the rate of joint damage progression and maintained an overall low disease activity throughout the treatment period, according to new data from the long-term extension of Phase 3 trials.

The results were presented on June 16 at an oral presentation and two poster presentations at the 2017 European Congress of Rheumatology (EULAR) meeting in Madrid.

“Rheumatoid arthritis is a chronic disease that is often associated with serious infections,” said presenting author Kevin L. Winthrop, M.D., M.P.H., assistant professor at Oregon Health and Science University. “These results suggest that baricitinib treatment may not increase the incidence of serious infections in patients with moderate-to-severe rheumatoid arthritis compared to placebo.”

A Once-daily Oral JAK Inhibitor

Olumiant® (baricitinib) is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The drug is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to or who are intolerant to one or more disease-modifying antirheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate.

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, respectively.

In a set of four clinical trials, incidence rates of serious infections per 100 patient-years in the 2 mg and 4 mg groups were 4.2 and 5.7, respectively, compared with 5.1 in the placebo group in this set.

The study also identified the key risk factors for serious infections: concomitant corticosteroids use, prior biologics use, non-normal BMI, Asian region of enrollment, and advancing age.

In an analysis of efficacy data, progression of structural joint damage-measured by change in the van der Heijde modified total Sharp score-was significantly lower at two years in patients treated with baricitinib throughout the two-year period compared with those who were first treated with placebo or methotrexate before switching to baricitinib.

In a second analysis of up to two years in a long-term extension study, among patients treated with baricitinib for up to three years, the proportion of patients with low disease activity at 24 weeks in different treatment groups across trials remained similar or increased up to three years.

Response Maintained

Most patients who had responded to treatment before entering the long-term extension study maintained their response throughout the two-year extension period.

In this study, achieving a Simplified Disease Activity Index (SDAI) score ≤ 11 was considered low disease activity.

“We are pleased to present these data, which support the evidence that baricitinib may be a potential long-term, oral treatment option for people with moderate-to-severe RA, many of whom are not achieving treatment goals with existing therapies,” said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines.

Baricitinib was approved in the European Union in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis.

The results were announced by Eli Lilly and Company and Incyte Corporation.