Eli Lilly's Oral JAK Inhibitor Olumiant (Baricitinib) Demonstrates Consistent Safety Profile Over Up to 9.3 Years in Rheumatoid Arthritis Treatment

November 11, 2021 /BioValleyBIOON/ --Eli Lilly(Eli Lilly) and its partner Incyte recently announced at the 2021 American College of Rheumatology Virtual Annual Meeting (ACR Convergence 2021)Oral JAK Inhibitor Olumiant® (Baricitinib) for the Treatment of Rheumatoid Arthritis (RA)New data. The results show,In a long-term integrated safety analysis of RA patients treated with Olumiant for up to 14,744 patient-years, Olumiant maintained a safety profile consistent with previously published results.In addition, the meeting also announced the real-world safety results for 3,445 RA patients in Japan. Detailed and additional results from the long-term integrated safety study of Olumiant were recently published in the international journal Annals of the Rheumatic Diseases. For more details, see:Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database | Annals of the Rheumatic Diseases。

Olumiant is an oral JAK inhibitor discovered by Incyte and licensed toEli LillyIn China, Olumiant (艾乐明® , baricitinib tablets) 2mg tablets were approved in July 2019 for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). Olumiant is a tyrosine protein kinase (JAK) 1/2 inhibitor administered orally once daily. It is indicated for adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). It can be used in combination with methotrexate or other non-biologic DMARDs.

Peter C.Taylor, Professor of Musculoskeletal Sciences at the University of Oxford and lead author of the long-term integrated safety analysis, stated: "RA is a chronic inflammatory disease that requires long-term treatment to control symptoms, including joint pain, swelling, and tenderness, which can lead to severe complications if left uncontrolled. As one of the longest safety trials of a JAK inhibitor in this disease, these data can help healthcare providers and RA patients better understand Olumiant when considering treatment options for long-term use."

Eli LillyGlobalImmunologyLotus Mallbris, MD, Vice President of Development, U.S. and Global Medical Affairs, said: "Within the JAK inhibitor class, Olumiant has one of the largest and longest available safety datasets, covering a total of 19,000 patient-years of exposure throughout more than 9 years of its clinical development program, including nearly 15,000 patient-years in RA.We are pleased to present this extensive dataset at ACR, which demonstrates the long-term safety of Olumiant in RA. When compared overall with previously published and well-established efficacy data, these new insights further characterize Olumiant's benefit/risk profile and support healthcare professionals and patients affected by this debilitating disease in making more informed treatment decisions.

A pooled analysis of nine randomized studies and one long-term extension study assessed the safety of 3770 RA patients taking Olumiant 4mg and 2mg over the long term, with these patients having received14,744 patient-years of treatment exposure, with a median exposure time of 4.6 years and a maximum exposure time of 9.3 years.

In patients receiving Olumiant treatment, the overall incidence rate of adverse events was 22.6 per 100 patient-years of exposure, and the incidence rate of serious adverse events was 7.4. Over 14,744 patient-years of exposure, the incidence rate remained stable over time. The incidence rate of serious infections was 2.58 cases 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), which were within the range of incidence rates described in general RA population epidemiological studies.

In patients treated with Olumiant,The incidence of special attention safety events remained stable during the exposure period of up to 9.3 years and was generally similar between the Olumiant 2mg group and the 4mg group.. Aged 50 years or older with at least one cardiovascular risk factor (current smoker,Hypertension, High-density lipoprotein cholesterol <40 mg/dL,DiabetesIn the subgroup of patients with or arterial sclerosis cardiovascular disease, the incidence of major adverse cardiovascular events (MACE) was 0.77 per 100 patient-years of exposure, compared to 0.51 in the overall study population.

In this study, the incidence of malignancies adjusted for age in patients treated with OlumiantTumorThe incidence rate (rate=0.92) and mortality rate (rate=0.6) are similar to those of the general population in the United States.

A post-marketing surveillance study evaluating the safety of using Olumiant 4mg and 2mg in clinical practice among 3,445 Japanese RA patients did not identify any new safety signals. In this population, 54% of the patients were aged 65 years or older, and 65% initiated treatment with the starting dose of Olumiant 4mg/day. Three-quarters (74%) of the patients continued treatment for 24 weeks, with most maintaining a consistent dose.

Overall, 26% of patients (n=887) reported adverse events, 4% of patients (n=122) reported serious adverse events, and there were six deaths, none of which were related to deep vein thrombosis or pulmonary embolism. Priority investigation events included herpes zoster (3%, n=100), hepatic dysfunction (3%, n=100), and severe infections (1.5%, n=51).Anemia(1%, n=41), hyperlipidemia (1%, n=40), malignancyTumor(0.3%, n=11), interstitial pneumonia (0.2%, n=8), MACE (0.1%, n=5), and venous thromboembolism (0.1%, n=3).

Olumiant's active pharmaceutical ingredient is baricitinib, a selective and reversible JAK1 and JAK2 inhibitor currently under clinical development for various inflammatory diseases.AutoimmuneTreatment of autoimmune diseases, including rheumatoid arthritis (RA), psoriasis,DiabetesKidney disease, Atopic Dermatitis (AD), SystemicSystemic Lupus Erythematosus(SLE), etc. There are four types of JAK enzymes, namely JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines are involved in various inflammatory processes andAutoimmuneThe pathogenesis of sexually transmitted diseases suggests that JAK inhibitors may be widely used to treat various inflammatory diseases. In kinase assays, baricitinib demonstrated 100 times greater inhibitory potency against JAK1 and JAK2 than against JAK3.

Olumiant is an oral JAK inhibitor discovered by Incyte and licensed toEli LillyAs of now, Olumiant has been approved and launched in more than 75 countries (including the United States, China, the European Union, and Japan) for the treatment ofModerate to Severe Active Rheumatoid Arthritis (RA)Adult patients. In addition, Olumiant has been approved for treatment in more than 50 countries, including the entire European Union and Japan.Moderate to Severe Atopic Dermatitis (AD)Adult patients. Meanwhile, Olumiant has also been approved in multiple countries for the treatment of hospitalized adult patients withPneumonia related to COVID-19.

In the treatment of RA, the approved doses of Olumiant are 4mg and 2mg in the EU, 2mg in the US, and 2mg in China. Regarding administration, Olumiant is taken orally once daily, either as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (non-biologic DMARDs). It is not recommended to use Olumiant in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine. Notably, the US drug label for Olumiant includes a black box warning regarding the risks of serious infections and malignancies.TumorAnd the risk of thrombosis. (Bioon.com)

Source of the original text:OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis