Eli Lilly & Co. (LLY) Announces Presentation of Baricitinib Phase 3 Data in RA, Other Baricitinib at Upcoming Meeting

November 3, 2016 1:18 PM EDT

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Eli Lilly & Co. (NYSE: LLY) announced that new post-hoc analyses of pooled efficacy and safety data from baricitinib phase 3 studies, along with findings from a real-world assessment of medication use among rheumatoid arthritis (RA) patients and other phase 2 studies, will be presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016. Additionally, six abstracts, including one oral presentation, will feature results from pivotal phase 3 data of Taltz® (ixekizumab) for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.

"The positive data to be presented at ACR provide further support for baricitinib as a potential treatment option for rheumatoid arthritis patients," said J. Anthony Ware, M.D., senior vice president, product development, Lilly Bio-Medicines. "We look forward to presenting these new results, along with other important data from our immunology portfolio, as we continue our work to address and alleviate unmet needs people living with chronic autoimmune diseases face."

Highlighted presentations and posters include:

Baricitinib

Sunday, November 13, 2016, 9:00am – 11:00am EST – POSTER PRESENTATIONS

  • Biologic Initiation Patterns Among Rheumatoid Arthritis Patients in Moderate or High Disease Activity While Using Conventional Disease Modifying Anti-Rheumatic Drugs (Presenting Author: Boytsov, N.) Abstract Number: 637
  • Drivers of the SLE Responder Index (SRI) Endpoint in Clinical Trials of SLE (Presenting Author: Kalunian, K.) Abstract Number: 784

Monday, November 14, 2016, 9:00am – 11:00am EST – POSTER PRESENTATIONS

  • Baricitinib Exposure-Efficacy Relationship in Rheumatoid Arthritis Patients from Integrated Analyses of Phase 2 and Phase 3 Studies (Presenting Author: Ernest, C.) Abstract Number: 1584
  • Previous Use of Conventional Disease-Modifying Antirheumatic Drugs and Response to Baricitinib (Presenting Author: Kavanaugh, A.) Abstract Number: 1585
  • Efficacy and Safety of Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs: A United States Subpopulation Analysis from Two Phase 3 Trials (Presenting Author: Wells, A.) Abstract Number: 1586
  • Safety and Efficacy of Baricitinib in Elderly Patients with Moderate to Severe Rheumatoid Arthritis (Presenting Author: Fleischmann, R.) Abstract Number: 1590
  • Efficacy and Safety of Switching from Adalimumab to Baricitinib: Phase 3 Data in Patients with Rheumatoid Arthritis (Presenting Author: Taylor, P.) Abstract Number: 1591
  • Speed of Onset of Effect on Patient-Reported Outcomes Assessed through Daily Electronic Patient Diaries in the Baricitinib Phase 3 RA Clinical Program (Presenting Author: Taylor, P.) Abstract Number: 1599
  • Effect of BMI on Baricitinib Efficacy: Pooled Analysis from Two Phase 3 Rheumatoid Arthritis Clinical Trials (Presenting Author: Zerbini, C.) Abstract Number: 1640

Tuesday, November 15, 2016, 9:00am – 11:00am EST – POSTER PRESENTATIONS

  • Biologic DMARD Use Among U.S. Patients in an Online Rheumatoid Arthritis Community (Presenting Author: Chang, L.) Abstract Number: 2237
  • RA Medication Preferences Among U.S. Patients in an Online Rheumatoid Arthritis Community (Presenting Author: Zhu, B.) Abstract Number: 2238
  • DMARD, Biologic and Small Molecule Drug Use Among ACPA Positive and ACPA Negative RA Patients in a Tertiary Referral Center (Presenting Author: Meehan, R.) Abstract Number: 2496
  • Prevalence of Anemia Among Rheumatoid Arthritis Patients Treated With Conventional Disease-Modifying Antirheumatic Drugs (Presenting Author: Kay, J.) Abstract Number: 2584
  • Effects of Baseline Patient Characteristics on Baricitinib Efficacy in Patients with Rheumatoid Arthritis (Presenting Author: Kremer, J.) Abstract Number: 2632

Tuesday, November 15, 2016, 2:30pm – 4:30pm EST – ORAL PRESENTATIONS

  • A Molecular Signature Based on IFN Gene Signature and Serology Defines Two Populations of Patients with Different Baseline Disease Activity in a Large Multinational Phase 3 SLE Trial Population (Presenting Author: Petri, M.) Abstract Number: 2991
  • Lipid Profile and Effect of Statin Treatment in Pooled Phase 2 and Phase 3 Baricitinib Studies (Presenting Author: McInnes, I.) Abstract Number: 3023
  • Herpes Zoster in Patients with Moderate to Severe Rheumatoid Arthritis Treated with Baricitinib (Presenting Author: Winthrop, K.) Abstract Number: 3027

Taltz Data

Sunday, November 13, 2016, 2:30pm – 4:00pm EST – ORAL PRESENTATION

  • Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52 week Results from a Phase 3 Study (Presenting Author: Mease, P.) Abstract Number: 959

Monday, November 14, 2016, 9:00am – 11:00am EST – POSTER PRESENTATIONS

  • Association of Early Skin Improvement with ACR Responses Among Biologic DMARD-Naive Psoriatic Arthritic Patients Treated with Ixekizumab (Presenting Author: Birt, J.) Abstract Number: 1686
  • Effect of Concomitant Conventional Disease-Modifying Antirheumatic Drugs (DMARDs) on the Efficacy and Safety of Ixekizumab in Biologic DMARD-Naive Patients with Active Psoriatic Arthritis (Presenting Author: Lin, C.) Abstract Number: 1687
  • Ixekizumab Provides Sustained Improvement up to 52 Weeks of Disease Activity as Assessed by Composite Measure Scores in Biologic Disease-Modifying Antirheumatic Drug -Naive Patients with Active Psoriatic Arthritis (Presenting Author: Coates, L.) Abstract Number: 1688
  • Ixekizumab Provides Improvements Through 52 Weeks in Physical Function, Quality of Life, and Work Productivity in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis (Presenting Author: Gladman, D.) Abstract Number: 1689
  • Sustained Efficacy of Ixekizumab in Patients with Moderate-to-Severe Plaque Psoriasis and Concomitant Psoriatic Arthritis (Presenting Author: Burge, R.) Abstract Number: 1733


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