INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) will present new data for Olumiant (baricitinib) at the virtual European Congress of Rheumatology (EULAR 2020) taking place June 3-6, 2020. Highlights from Olumiant data being presented at the virtual meeting include new long-term data in patients living with rheumatoid arthritis (RA) as well as data from an investigational trial in patients with systemic lupus erythematosus (SLE).

'We're pleased to be participating in this year's virtual EULAR meeting sharing new safety and efficacy data in people living with RA who have been treated with Olumiant,' said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. 'At Lilly, our focus on patient needs doesn't stop when we launch a product. We're committed to continuously evaluating potential treatment options for patients living with rheumatic conditions.'

At this year's meeting, Lilly will share results from a long-term study that evaluated the efficacy of Olumiant in patients with moderate to severe RA during three years of treatment. The study measured the achievement of clinically-relevant outcomes, including low disease activity (LDA) as measured by the simplified disease activity index (SDAI ?11), in DMARD-naive patients and patients with an inadequate response to methotrexate (MTX-IR) from treatment initiation to three years. Patients in this study were treated with Olumiant 4-mg once daily, an approved dose outside of North America.

The study found that among patients with an inadequate response to MTX, 52% of patients initially treated with Olumiant (+MTX) were in a state of SDAI LDA at week 24 and this rate was maintained through week 148.

Lilly will also share an updated integrated safety analysis of Olumiant in the treatment of RA using data from 3,770 patients who were treated with the medicine for up to 8.4 years. The study found that Olumiant's safety profile remains consistent with what has been previously reported, with no increase in the rates of safety topics of interest, including serious infections, herpes zoster, major adverse cardiovascular events, deep-vein thrombosis and/or pulmonary embolism, non-melanoma skin cancer (NMSC), and non-NMSC malignancies. No new safety signals were identified.

'The results from Lilly's integrated safety analysis help to further characterize the long-term safety of Olumiant as a treatment option in patients with RA,' said Kevin Winthrop, professor of medicine at the Oregon Health and Sciences University and author of the Olumiant safety abstract.

In addition, Lilly will present analyses from an investigational trial evaluating baricitinib in patients with SLE at EULAR. Data from its Phase 2 randomized, placebo-controlled, double-blind JAHH study will be highlighted, which observed whether or not SLE patients experienced changes in their serum cytokine levels when being treated with the 4-mg dose of baricitinib.

For more information about the Lilly data being presented at this year's virtual EULAR congress, please visit https://www.congress.eular.org/scientific_programme.cfm.

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: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

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. Treatment for latent infection should be considered 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.

WARNINGS AND PRECAUTIONS

SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

with chronic or recurrent infection

who have been exposed to TB

with a history of a serious or an opportunistic infection

who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or

with underlying conditions that may predispose them to infection.

Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

Tuberculosis - Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

Viral Reactivation - Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS: Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES:

Neutropenia - Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC]

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