Eli Lilly's oral JAK inhibitor Olumiant (Baritinib): 9.3 years of treatment, with long-term good safety!
2021-11-19
OLUMIANT® (baricitinib) maintained a consistent safety profile in a long-term, integrated safety analysis of patients with rheumatoid arthritis (RA) who received OLUMIANT for 14,744 patient years of exposure, in line with previously published findings. Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) will present these results, along with real-world safety results from 3,445 patients with RA in Japan, at ACR Convergence 2021, the American College of Rheumatology's virtual annual meeting taking place November 3-9, 2021. Detailed and additional results from the long-term, integrated safety study for OLUMIANT were recently published in the Annals of the Rheumatic Diseases.
"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, M.D., Ph.D., 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."
OLUMIANT RA Safety Profile Remains Consistent Up to 9.3 Years
A pooled analysis across nine randomized studies and one long-term extension study evaluated the safety of OLUMIANT 4-mg and OLUMIANT 2-mg over time in 3,770 patients with RA, who were exposed to treatment for a total of 14,744 patient years of exposure. Participants had a median exposure of 4.6 years and a maximum exposure of 9.3 years.
Among those treated with OLUMIANT, the overall incidence rate of adverse events per 100 patient years of exposure was 22.6, and the incidence rate of serious adverse events was 7.4. Incidence rates remained stable over time across the 14,744 patient years of exposure. The incidence rate of serious infections was 2.58 per 100 patient years of exposure.
Adverse events of special interest included venous thromboembolic events (pulmonary embolism, incidence rate=0.26; deep vein thrombosis, incidence rate=0.35; deep vein thrombosis and/or pulmonary embolism, incidence rate=0.49) and major adverse cardiovascular events (incidence rate=0.51) within the range of incidence rates described in epidemiological studies in the general RA population. Incidence rates of safety events of special interest among those treated with OLUMIANT remained stable through exposures up to 9.3 years and were generally similar between the OLUMIANT 2-mg and 4-mg groups. In a subgroup of patients over 50 years old who had at least one cardiovascular risk factor (current smoker, hypertension, high-density lipoprotein cholesterol <40 mg/dL, diabetes, or arteriosclerotic cardiovascular disease), the incidence rate of major adverse cardiovascular events (MACE) was 0.77 per 100 patient years of exposure vs. 0.51 in the total study population.
In this study, age-adjusted incidence rates for malignancy (incidence rate=0.92) and mortality (incidence rate=0.6) for patients treated with OLUMIANT appear similar to the general U.S. population.
For methodology, see the full abstract on the ACR website.
Real-World Evidence Study Reinforces OLUMIANT 4-mg and 2-mg Safety Profile at 24-Weeks
A post-marketing surveillance study of 3,445 patients with RA in Japan evaluated the safety of OLUMIANT 4-mg and OLUMIANT 2-mg in clinical practice and no new safety signals were identified. Of the population, 54% were 65 years or older, and 65% started with an initial dose of OLUMIANT 4-mg/day. Three out of four patients in the study (74%) continued treatment for 24 weeks, and the majority of patients maintained a consistent dosage.
Overall, 26% of patients (n=887) reported an adverse event and 4% of patients (n=122) reported a serious adverse event, with six deaths, none of which were related to deep vein thrombosis or pulmonary embolisms. Priority survey events included herpes zoster (3%, n=100), liver dysfunction (3%, n=100), serious infection (1.5%, n=51), anemia (1%, n=41), hyperlipidemia (1%, n=40), malignancy (0.3%, n=11), interstitial pneumonia (0.2%, n=8), MACE (0.1%, n=5) and venous thromboembolism (0.1%, n=3).
For methodology, see the full abstract on the ACR website.
"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, M.D., Ph.D., vice president of global immunology development and U.S. and global medical affairs at Lilly. "We are pleased to pre
