Integrated safety analysis of Olumiant over six years--Eli Lilly + Incyte

Eli Lilly and Company and Incyte Corporation announced findings from an updated integrated safety analysis of Olumiant (baricitinib) based on an ongoing long-term extension (LTE) study of rheumatoid arthritis (RA) patients treated up to six years. The analysis provides further support for the characterization of Olumiant's safety profile, and was shared as an oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago, Illinois. Olumiant is indicated in the U.S. for the treatment of adults with moderately-to-severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

This long-term safety evaluation of Olumiant included all patients with active RA exposed to the medicine during eight randomized trials (including four Phase III, three Phase II and one Phase 1b studies) and one LTE study (with data cut-off at April 1, 2017). Dose responses were evaluated based on the four Phase II/III trials in which patients were randomized to receive the 2-mg or 4-mg dose of baricitinib, including data from the LTE (the 4-mg dose of baricitinib is not approved for use in the U.S.). Incidence rates (IR) were calculated per 100 patient-years (PY). In total, 3,492 patients received Olumiant for 7,860 patient-years of exposure (PYE). More than three-quarters of these patients were treated for at least one year, and half were treated for at least two and a half years.

Key findings from the analysis include: Overall, adverse event (AE) IRs per 100 PYE were consistent with prior analyses, and did not show evidence of increase with longer-term treatment. The malignancy (excluding non-melanoma skin cancer) IR was 0.8. The major adverse cardiovascular event (MACE) IR was 0.5. The serious infection IR was 3.0. The IR for venous thromboembolism (VTE), which combined events of deep venous thrombosis (DVT) and pulmonary embolism (PE), was 0.5. Fewer than 1.0 percent of patients discontinued treatment with Olumiant due to abnormal lab results. The permanent discontinuation IR due to AEs was 5.4. Follow up investigations will continue to assess Olumiant's long-term safety profile, including malignancies, VTE and MACE. Later in the meeting, Lilly will share an updated analysis of cardiovascular safety data from patients with moderately-to-severely active RA treated with Olumiant for up to six years.