November 02, 2020: “Eli Lilly and Company and Incyte announced positive data for Olumiant® (baricitinib) will be presented at ACR Convergence 2020, the American College of Rheumatology’s virtual annual meeting taking place November 5-9, 2020.
The Olumiant data being presented at this year’s meeting include new long-term studies in adult patients living with rheumatoid arthritis (RA), along with real-world evidence (RWE) on safety and efficacy.
At this year’s meeting, results from a post-hoc analysis evaluating the long-term efficacy of Olumiant for patients with active RA who were inadequate responders (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD) will be shared.
In this analysis, 27.5% of the csDMARD-IR and 18.4% of the bDMARD-IR patients had Low Disease Activity defined by Simple Disease Activity Index (LDA; SDAI ≤11) after 2.3 years (at week 120) in a Non-responder Imputation analysis.
For those patients who remained in the study, 85% and 86% of csDMARD-IR and bDMARD-IR respectively, maintained low disease activity at 2.3 years. No new safety concerns were identified.
“In this analysis of the long-term studies of Olumiant in adults with RA, the medicine demonstrated efficacy over more than two years as measured by the proportion of patients who achieved low disease activity,” said Alvin Wells, M.D., Ph.D., director of the Aurora Rheumatology and Immunotherapy Center.
“The safety and efficacy from this study helps support Olumiant 2-mg once daily as a long-term treatment for patients with moderate to severe RA.”
Lilly will also highlight data from a long-term extension study that evaluated radiographic progression of structural joint damage in adult patients with active RA over 5 years of treatment with Olumiant.
The study enrolled patients who had completed treatment in one of three Phase 3 trials, including patients who were DMARD-naïve, csDMARD-IR and methotrexate (MTX)-IR, and assessed baricitinib 4-mg once daily as monotherapy or in combination with MTX or other csDMARDs and baricitinib 2-mg once daily in combination with other csDMARD.
The data suggest that the different RA patient populations treated with baricitinib for up to 5 years can maintain low rates of radiographic progression, as assessed by the van der Heijde modified Total Sharp Score (mTSS).
“We are pleased with the data being presented at this year’s virtual ACR meeting highlighting the depth of Lilly’s immunology portfolio and the potential impact our medicines may have for patients,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly.
“Furthermore, the data being showcased at this meeting demonstrate our commitment to ongoing evaluation of the long-term safety and efficacy of Olumiant in patients living with RA.”
Additionally, Lilly will showcase RWE from a postmarketing safety surveillance study. Results include 24-week safety data from 1,992 patients consecutively prescribed Olumiant in Japan.
No new safety signals were observed during the initial analysis, and the study will continue to collect serious adverse events for three years.
An integrated safety analysis of pooled data from nine clinical trials of Olumiant is also being presented.
Across the trials, 3,770 patients with RA received Olumiant for a total of 13,148 patient-years of exposure with a median time on treatment of 4.2 years and up to a maximum of 8.4 years.
The data reinforce the safety profile of Olumiant in the treatment of RA, with no new safety concerns reported in the analysis.
For more information about the Lilly data being presented at this year’s virtual ACR, please visit https://www.rheumatology.org/Annual-Meeting.
Olumiant, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.
Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients
OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS
SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death.
Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
- Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease.
Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use. - Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic pathogens.
Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.
THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo.
In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death.
Patients with symptoms of thrombosis should be promptly evaluated.“
https://investor.lilly.com/news-releases/news-release-details/acr-2020-lilly-and-incyte-highlight-positive-data-olumiantr
