- Eli Lilly's rheumatoid arthritis (RA) drug baricitinib demonstrated significant improvement in symptoms, beating a placebo in a 12-week, phase 3 study, the company said Thursday.
- In the 527-person study, 55% of patients who received the higher dose of baricitinib experienced at least a 20% improvement in selected symptoms (a measurement known as ACR20). This compared favorably to the 27% of patients on the placebo who demonstrated an improved ACR20 response.
- Baricitinib is the only oral once-daily selective JAK1 and JAK2 inhibitor currently being developed for moderate-to-severe RA. Lilly filed a new drug application with the FDA on January 19.
The RA-BEACON trial is one of four phase 3 trials being used as an evidence base to support FDA approval. Patients in this trial had previously been treated with disease-modifying anti-rheumatic drugs and had an inadequate response. The ACR20 assesses the signs and symptoms of RA, including physical function, pain, fatigue and joint stiffness.
However, more baricitinib-treated patients experienced adverse events, compared with placebo-treated patients. Overall, 77% of patients treated with baricitinib 4 mg experienced adverse events such as infections, compared wth 64% of placebo-treated patients.
Nearly a third of patients fail to respond to the standard anti-rheumatic drugs, creating a significant medical need for the 1.5 million people in the US who live with RA.
Lilly has high hopes for the drug, which has demonstrated superiority in some measures to AbbVie's Humira.
"Our goal is to offer an oral option to patients that provides efficacy similar to the TNF drugs. Baricitinib is the only oral RA medication that has been studied in direct comparison to Humira (adalimumab) and actually beat it," said Tom Bumol, senior vice president of biotechnology and immunology at Lilly.
Other companies are also developing new therapies for RA. Sanofi and Regeneron are in phase 3 development of sarilumab, an IL-6 blocker. Sarilumab has also bested Humira, showing greater efficacy in phase 3 results announced earlier this month.
Elsewhere, Janssen and GSK are working on sirukumab, another IL-6 blocker, and have filed for approval with the FDA.
Decision Resources estimates that the RA market will grow to $15.2 billion by 2021.