Lilly's New Data at ACR 2017 Save

Eli Lilly and Company (NYSE: LLY) announced that it will present new data for baricitinib and Taltz® (ixekizumab) at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting taking place Nov. 3-8, 2017, in San Diego, Calif.

Lilly will feature new data for baricitinib in 17 abstracts, including six oral presentations on rheumatoid arthritis (RA) (Lilly and Incyte Corporation are partners on the development of baricitinib). Highlights include a new post-hoc analysis from RA-BEAM, a pivotal Phase 3 study, disclosing outcomes of patient-reported levels of pain control, as well as new findings from two safety analyses evaluating cardiovascular safety and long-term use of baricitinib in RA, respectively.

Additionally, Lilly will present eight abstracts featuring new data for Taltz, including two oral presentations. Highlights from the oral presentations include interim results from the extension period of the SPIRIT-P2 study evaluating the safety and efficacy of Taltz for the treatment of active psoriatic arthritis (PsA), in addition to a new analysis from the IXORA-S study comparing Taltz to Stelara®** (ustekinumab) for the treatment of nail lesions in patients with moderate-to-severe plaque psoriasis.

An additional eight abstracts will detail results from a selection of studies evaluating the impact of immune-mediated diseases.

"At Lilly, patients are at the heart of what we do every day," said Lotus Mallbris, M.D., vice president, immunology platform team leader, Lilly Bio-Medicines. "We are proud to present new data at ACR/ARHP from our continued research with the goal to help provide more treatment options for people living with autoimmune diseases."

Highlighted presentations and posters include: 

Baricitinib Data

Oral Presentations (All times PST)

Sunday, Nov. 5

•  Abstract 855: 2:30-4:00 p.m. o Rapid and Sustained Pain Improvement in Rheumatoid Arthritis Patients Treated with Baricitinib Compared to Adalimumab or Placebo o Presenter: Peter Taylor, M.A., Ph.D., F.R.C.P., F.R.C.P.E., University of Oxford, Oxford, United Kingdom

Monday, Nov. 6

• Abstract 1821: 2:30-4:00 p.m. o Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study o Presenter: Tsutomu Takeuchi, M.D., Ph.D., Keio University School of Medicine, Tokyo, Japan 
• Abstract 1824: 2:30-4:00 p.m. o Evaluation of Pneumococcal and Tetanus Vaccine Responses in Patients with Rheumatoid Arthritis Receiving Baricitinib: Results from a Long-Term Extension Trial Substudy o Presenter: Kevin Winthrop, M.D., M.P.H., Oregon Health and Science University, Portland, OR, United States

Tuesday, Nov. 7

• Abstract 2787: 2:30-4:00 p.m. o Tuberculosis, Potential Opportunistic Infections, and Other Infections of Interest in Patients with Moderate to Severe Rheumatoid Arthritis in the Baricitinib Program  Presenter: Kevin Winthrop, M.D., M.P.H., Oregon Health and Science University, Portland, OR, United States
• Abstract 2866: 4:30-6:00 p.m. o Microarray Pathway Analysis Comparing Baricitinib and Adalimumab in Moderate to Severe Rheumatoid Arthritis Patients, from a Phase 3 Study o Presenter: Paul Emery, M.D., Leeds MSK Biomed/Chapel Allerton Hospital, Leeds, United Kingdom
• Abstract 2870: 4:30-6:00 p.m. o Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib and Tofacitinib for Cytokine Signaling in Human Leukocyte Subpopulations o Presenter: Iain McInnes, M.D., Ph.D., University of Glasgow, Glasgow, United Kingdom

Poster Presentations (All times PST)

Sunday, Nov. 5

• Abstract 409: 9:00-11:00 a.m. o An Evaluation of Absolute Neutrophil Count as a Biomarker of Inflammatory and Clinical Disease Activity in Baricitinib-Treated Patients o Presenter: Iain McInnes, M.D., Ph.D., University of Glasgow, Glasgow, United Kingdom
• Abstract 415: 9:00-11:00 a.m. o Baricitinib Reduces GlycA Levels in Phase 2 and Phase 3 Clinical Trials in Patients with Moderate-to-Severe Rheumatoid Arthritis  Presenter: Joel Kremer, M.D., F.A.C.P., The Center for Rheumatology, Albany, NY, United States
• Abstract 418: 9:00-11:00 a.m.  Exploratory Analysis to Identify Factors Associated with Risk of Structural Progression, Defined as Change from Baseline  Presenter: Désirée van der Heijde, M.D., Ph.D., Leiden University Medical Center, Leiden, The Netherlands
• Abstract 499: 9:00-11:00 a.m. Assessment of Early Improvement in Pain and Other ACR components as Predictors for Achieving Low Disease Activity or Remission in Three Phase 3 Trials of Rheumatoid Arthritis Patients Treated with Baricitin  Presenter: Michael Weinblatt, M.D., Brigham and Women's Hospital, Boston, MA, United States
• Abstract 502: 9:00-11:00 a.m.  Reduction in Disease Activity in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Baricitinib Compared to Adalimumab and Placebo  Presenter: Peter Nash, M.D., University of Queensland, Queensland, Australia
• Abstract 508: 9:00-11:00 a.m.  Improved Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Who Failed Adalimumab or Placebo Treatment and Were Rescued with Baricitinib  Presenter: Bruno Fautrel, M.D., Ph.D, Pitié Salpêtrière University, Paris, France
• Abstract 511: 9:00-11:00 a.m. Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 5.5 Years: An Updated Integrated Safety Analysis  Presenter: Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, CA, United States 
• Abstract 512: 9:00-11:00 a.m. Efficacy Response to Baricitinib Based on Baseline Characteristics in Patients Who Are Inadequate Responders to Conventional DMARD  Presenter: Maxime Dougados, M.D., Rene Descartes University, Cochin Hospital, Paris, France
• Abstract 513: 9:00-11:00 a.m.  Time to Achieve Moderate/Low Disease Activity and Remission in Rheumatoid Arthritis Patients on Baricitinib Compared to Adalimumab, Methotrexate and Placebo  Presenter: Edward Keystone, M.D., The University of Toronto, Toronto, ON, Canada

Tuesday, Nov. 7

• Abstract 2219: 9:00-11:00 a.m.   Remaining Pain in DMARD-naive Rheumatoid Arthritis Patients Treated with Baricitinib and Methotrexate   Presenter: Yvonne Lee, M.D., Brigham and Women's Hospital, Boston, MA, United States 
• Abstract 2352: 9:00-11:00 a.m. Cardiovascular Safety during Treatment with Baricitinib in Rheumatoid Arthritis   Presenter: Michael Weinblatt, M.D., Brigham and Women's Hospital, Boston, MA, United States

Taltz Data

Oral Presentations (All Times PST)

Monday, Nov. 6

• Abstract 1827: 2:30-4:00 p.m.  Comparison of Ixekizumab and Ustekinumab Efficacy in the Treatment of Nail Lesions of Patients with Moderate-to-Severe Plaque Psoriasis: 24-Week Data from a Phase 3 Trial  Presenter: David Sandoval, Eli Lilly and Company, Indianapolis, IN, United States

Wednesday, Nov. 8

• Abstract 2969: 11:00 a.m.-12:30 p.m.   Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis and Previous Inadequate Response to TNF inhibitors: 52-week Results from a Phase 3 Study  Presenter: Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, CA, United States

Poster Presentations (All Times PST)

Sunday, Nov. 5

• Abstract 597: 9:00-11:00 a.m. o Ixekizumab Improves Patient-Reported Outcomes Through 52 Weeks in Patients with Active Psoriatic Arthritis and Previous Inadequate Response to Tumor Necrosis Factor-Inhibitors   Presenter: Arthur Kavanaugh, M.D., University of California, San Diego, La Jolla, CA, United States 
• Abstract 605: 9:00-11:00 a.m. Ixekizumab Exhibits a Favorable Safety Profile During 24 Weeks of Treatment in Subjects with Active Psoriatic Arthritis: Integrated Safety Analysis of Two Randomized, Placebo Controlled, Phase 3 Clinical Trials  Presenter: Philip J. Mease, M.D., Swedish Medical Center and University of Washington, Seattle, WA, United States
• Abstract 624: 9:00-11:00 a.m. Ixekizumab Provides Sustained Improvement in Signs and Symptoms in Patients with Active Psoriatic Arthritis: Two Year Results from a Phase 3 Trial   Presenter: Philip S. Helliwell, St. Luke's Hospital and University of Leeds, Bradford, United Kingdom
• Abstract 625: 9:00-11:00 a.m. Rapid Onset of Efficacy in Patients with Active Psoriatic Arthritis Treated with Ixekizumab: A Pooled Analysis of Data from Two Phase 3 Clinical Trials  Presenter: Atul A. Deodhar, M.D., M.R.C.P., Oregon Health and Science University, Portland, OR, United States 
• Abstract 626: 9:00-11:00 a.m. Radiographic Progression of Structural Joint Damage in Patients with Active Psoriatic Arthritis Treated with Ixekizumab over 52 Weeks  Presenter: Désirée van der Heijde, M.D., Ph.D., Leiden University Medical Center, Leiden, The Netherlands
• Abstract 628: 9:00-11:00 a.m. Integrated Efficacy Results from Two Phase 3 Trials of Ixekizumab for the Treatment of Psoriatic Arthritis  Presenter: Bernard Combe, M.D., Ph.D., CHU Lapeyronie and Montpellier University, Montpellier, France