Eli Lilly and partner Incyte have revealed that their JAK inhibitor Olumiant maintained a consistent safety profile in a long-term analysis of patients with rheumatoid arthritis (RA).
A pooled analysis from across nine randomised studies, plus a long-term extension study, evaluated the safety of Olumiant 4mg and 2mg over time in 3,770 patients with RA.
These patients were exposed to treatment for a total of 14,744 patient years of exposure, with participants having a median exposure of 4.6 years and a maximum exposure of 9.3 years.
Patients treated with Olumiant had an overall incidence rate of adverse events per 100 patient years of exposure was 22.6, while the incidence rate of serious adverse events was 7.4.
The incidence rates remained stable over time across the 14,744 patient years of exposure, with the incidence rate of serious infections found to be 2.58 per 100 patient years of exposure.
According the data, adverse events of special interest included venous thromboembolic events and major adverse cardiovascular events within the range of incidence rates describe in epidemiological studies in the general RA population.
“Rheumatoid arthritis is a chronic inflammatory disease that requires long-term treatment to manage symptoms, including joint pain, swelling and tenderness, and if left uncontrolled, can be associated with significant morbidity complications,” said Peter C. Taylor, professor of Musculoskeletal Sciences at the University of Oxford, and lead author of this analysis.
“As one of the longest safety trials for a JAK inhibitor in this disease, these data can help healthcare providers and people living with rheumatoid arthritis in better understanding Olumiant when considering treatment options that can be used for prolonged periods of time,” he added.
