Baricitinib (Olumiant, Eli Lilly) maintained a consistent safety profile in a long-term, integrated safety analysis of patients with rheumatoid arthritis (RA), according to a press release from Eli Lilly and Company. The company presented the full results of the study, as well as real-world safety results from 3445 patients with RA in Japan, at ACR Convergence 2021, the American College of Rheumatology's virtual annual meeting.
"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 professor Peter C. Taylor, MD, PhD, professor of musculoskeletal sciences at the University of Oxford, in a press release. "As one of the longest safety trials for a JAK inhibitor in this disease, these data can help health care providers and people living with rheumatoid arthritis in better understanding Olumiant when considering treatment options that can be used for prolonged periods of time."
The investigators analyzed the safety of baricitinib across 9 randomized studies and 1 long-term extension study in a total of 3770 patients. Study participants had a median treatment exposure of 4.6 years and a maximum exposure of 9.3 years, with a combined total of 14,744 patient years of exposure.
According to the study, the overall incidence rate of adverse events (AEs) per 100 patient years of exposure was 22.6, and the incidence rate of serious AEs was 7.4. These rates remained stable over time, and the rate of serious infections was 2.58 per 100 patient years of exposure.
AEs of special interest included pulmonary embolism with an incidence rate of 0.26, deep vein thrombosis, with a 0.35 incidence rate, and major adverse cardiovascular events, with an incidence rate of 0.51. In the post-marketing surveillance study of 3445 patients with RA in Japan, no new safety signals were identified. Overall, 26% of participants reported an AE and 4% of patients reported a serious AE, with 6 deaths occurring, none of which were related to deep vein thrombosis or pulmonary embolisms.
"Olumiant has one of the largest and longest sets of available safety data in the JAK inhibitor class, spanning 19,000 total patient years of exposure, including almost 15,000 patient years in RA, over a period of over nine years across the clinical development program," said Lotus Mallbris, MD, PhD, vice president of global immunology development and US and global medical affairs at Lilly, in the release. "We are pleased to present this extensive set of data at ACR, which illustrate Olumiant's long-term safety profile in rheumatoid arthritis. When taken in totality with previously published, well-established efficacy data, these new insights further characterize the benefit/risk profile of Olumiant and support better informed treatment decisions by HCPs and patients affected by this painful disease."
Olumiant® long-term safety profile established up to 9.3 years in integrated analysis of more than 3,700 patients with rheumatoid arthritis [news release]. Eli Lilly; November 9, 2021. Accessed November 10, 2021. https://investor.lilly.com/news-releases/news-release-details/olumiantr-long-term-safety-profile-established-93-years