The Lancet has published full results of a Phase II trial showing the benefit of Lilly’s JAK inhibitor Olumiant in the treatment of global systemic lupus erythematosus (SLE).
According to the data, a statistically significant proportion of patients treated with 4mg of Olumiant (baricitinib) achieved resolution of their SLE-related arthritis or rash compared to placebo at week 24, thus meeting the primary endpoint of the trial.
Also, compared to placebo, treatment with the drug resulted in a statistically significantly greater proportion of patients with lower overall disease activity, a key secondary endpoint.
Based on these data, Lilly will initiate Phase III trials to evaluate the safety and efficacy of Olumiant for the treatment of SLE.
“Systemic lupus erythematosus is a chronic, multi-organ autoimmune disease characterized by periods of flare and remission and is associated with a variety of symptoms, including joint pain and swelling,” said Daniel Wallace, lead author and Professor of Medicine and Associate Director of the Rheumatology Fellowship Program at Cedars-Sinai Medical Center.
“Notably, these Phase II data showed improvements in pain associated with SLE, one of the more challenging symptoms for these patients, and I look forward to the investigation of baricitinib in Phase III trials for SLE.”
Olumiant is already approved in more that 40 countries as a treatment for rheumatoid arthritis.