Olumiant (baricitinib) improved patients’ outcomes in the treatment of moderate-to-severe rheumatoid arthritis (RA), in comparison to placebo and a current standard treatment, Humira (adalimumab).
These findings were published in The New England Journal of Medicine in an article titled “Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis”.
RA-BEAM (NCT01710358) was a 52-week, phase 3, double-blind, placebo- and active-controlled trial that evaluated the effectiveness and safety of Olumiant in 1,307 patients with moderate-to-severe active RA, who had an inadequate response to methotrexate.
Patients were randomly assigned to treatment with either 4 mg of Olumiant once daily, 40 mg of Humira (an injectable biologic anti-TNF medication) every other week, or placebo (switched to Olumiant after 24 weeks).
Results showed that Olumiant is more effective than Humira in improving the symptoms of RA. Specifically, from week eight to week 52, more patients taking Olumiant achieved ACR50 and ACR70 response, as compared to Humira. ACR score is a standard clinical measure developed by the American College of Rheumatology (ACR) and represents, in this case, a 50% and 70% improvement in RA disease activity.
Results from the study also showed that patients treated with Olumiant had lower levels of disease activity, in comparison to patients treated with Humira, at weeks 12 and 52.
In terms of safety, the percentage of patients who were forced to stop treatment due to adverse events, including infections, through week 24 were: 3% for placebo, 5% for Olumiant, and 2% for Humira.
While biologic drugs such as Humira need to be administered by injection or intravenously, Olumiant is a low molecular weight drug that can be taken as an oral medication once a day.
“Current biological injectable treatments ease the symptoms of rheumatoid arthritis and slow disease progression to protect joints from long-term damage, but can be painful to administer and do not work for all patients,” said Peter C. Taylor from the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, in a press release. Taylor was the lead investigator for the RA-BEAM clinical trial.
“Developing an oral treatment is a huge step forward to simplifying therapy. Early intervention is particularly important in slowing the progress of the disease and maintaining a normal lifestyle” Taylor added.
Olumiant is a Janus oral kinase (JAK) 1 and 2 inhibitor developed by Eli Lilly and Company and Incyte Corporation. Janus kinases are enzymes that transmit important cell signals, interacting with a number of proteins known as cytokines and growth factors in blood-cell formation, inflammation and immune function. Jak1 and Jak 2 are two enzymes known to play a key role in inflammation in RA.
Olumiant is recommended for those who failed to respond to, or were unable to tolerate, disease-modifying anti-rheumatic drugs (DMARDs), such as Rheumatrex and Trexall.
Olumiant has marketing authorization in the European Union for the treatment of moderate-to-severe active RA, either as monotherapy or in combination with methotrexate, and is in the late stages of regulatory review in the United States and Japan.