News Release

INDIANAPOLIS, June 1, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will present new data from Phase 3 studies that further demonstrated the long-term efficacy and safety profile of Taltz^® (ixekizumab) among patients with axial spondyloarthritis (axSpA). These results are being presented at the virtual Annual European Congress of Rheumatology (EULAR), June 2-5, 2021.

AxSpA is recognized as a single disease entity, with two subtypes which are defined depending on the presence (radiographic axSpA, or r-axSpA) or absence (non-radiographic axSpA, or nr-axSpA) of defined structural damage of the sacroiliac joints on plain x-ray films as per the modified New York (mNY) criteria.

"Patients living with axial spondyloarthritis deal with a range of chronic, debilitating symptoms, including inflammatory back pain, and are in need of treatment options that can provide long-term efficacy," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We are excited to present a range of new data at EULAR that demonstrate treatment with Taltz provides consistent, long-term efficacy on common signs and symptoms over time in axial spondyloarthritis."

Taltz Showed Sustained Long-Term Improvements in axSpA Through Two Years

In COAST-Y, Taltz showed consistent and sustained long-term improvements in signs and symptoms, functionality and quality of life in patients with r- and nr-axSpA. In this study, more than half of patients (56.7%) treated continuously with Taltz (80 mg every four weeks, n=157) through two years achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40).

Among those treated continuously with Taltz every four weeks for two years:

• 43.9% of patients achieved low disease activity status, as measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1. Mean change from baseline (3.9) in ASDAS score was -1.6.
• 19.7% achieved ASAS partial remission status.
• Mean change from baseline (6.6) in Bath Ankylosing Spondylitis Functional Index (BASFI) was -2.8.
• Mean change from baseline (33.9) in Medical Outcomes Survey Short Form 36 Physical Component Summary (SF-36 PCS) was 8.4.

The safety profile of Taltz was consistent with previously published safety data, and no new safety signals were observed after up to two years of treatment.

For methodology, see the "About the Analyses" section below. Additional results from the Phase 3 COAST-Y study were also recently published in the Annals of the Rheumatic Diseases.

Most Patients Treated with Taltz Did Not Show Bone Damage Progression of r-axSpA Up to Two Years

An analysis of two Phase 3 studies in r-axSpA (COAST-V and COAST-W) and the long-term extension trial (COAST-Y), found that 9 out of 10 patients treated with Taltz (89.6%, n=206) did not show radiographic progression for up to two years, as measured by mean change from baseline of modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) <2. Overall mean rates of progression were low among patients treated with Taltz. These results were similar among patients who were previously treated with anti-TNF therapy (88%, n= 106) and those who had not previously been treated with a biologic (91%, n=100). For methodology, see the "About the Analyses" section below.

"If left uncontrolled, individuals living with active radiographic axSpA can experience severe, chronic pain and structural damage in the spine that can lead to fusion of the spine and loss of mobility," said Walter P. Maksymowych, M.D., FRCP (C), Professor of Medicine at the University of Alberta, and Chief Medical Officer, CARE Arthritis, Edmonton, CA, and the senior author of this analysis. "Most patients treated with ixekizumab did not show structural damage progression at two years, and the degree of progression was small. In addition to known predictors, the novel finding is that attainment of remission of inflammation on MRI at one year protected from progression at two years."

Notably, Lilly will also present new analyses in axSpA and psoriatic arthritis, including the following:

• Baseline Characteristics and Treatment Response to Ixekizumab Categorized by Sex in Radiographic and Non-radiographic Axial Spondyloarthritis Patients Through 52 Weeks: Data From 3 Phase 3 Randomized Controlled Trials
• Ixekizumab Shows a Distinct Pattern of Pain Improvement Beyond Inflammation in Radiographic Axial Spondyloarthritis
• Ixekizumab Efficacy on Spinal Pain, Disease Activity and Quality of Life in Patients with Psoriatic Arthritis Presenting with Symptoms Suggestive of Axial Involvement

More than 175,000 patients have been treated with Taltz worldwide since launch, giving healthcare providers confidence in making informed prescribing decisions for the treatment of adults with active psoriatic arthritis, active ankylosing spondylitis, active nr-axSpA and moderate to severe plaque psoriasis.

About the Analyses

• Long-term Treatment with Ixekizumab in Patients with Axial Spondyloarthritis: 2-year Results from COAST-Y
• COAST-Y is the two-year extension of the COAST-V, COAST-W and COAST-X trials. Upon completion of the initial trials, 773 patients continued with the dose received at the end of the originating trial at Week 52, either with 80 mg Taltz every two weeks or four weeks. Patients who had been assigned to adalimumab or placebo were re-randomized to Taltz every two weeks or every four weeks at Week 16 in COAST-V and COAST-W. Patients who had received placebo for 52 weeks in COAST-X were switched to Taltz every four weeks in COAST-Y. For this analysis, only patients continuously treated with Taltz since the originating studies were included. All other patients were analyzed separately.
• Standardized efficacy measures were used. Missing data were handled by non-responder imputation for categorical data and modified baseline observation carried forward for continuous data. Safety data were analyzed for all patients who received ≥1 dose of Taltz.

• Evaluation of Spinal Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis Receiving Ixekizumab Therapy over 2 Years
• These analyses included biologic-naïve patients with active r-axSpA (COAST-V) or patients with prior inadequate response or intolerance to one or two TNF inhibitors (COAST-W) who received 80 mg Taltz every two weeks or four weeks for two years (108 weeks, of which 56 weeks were the COAST-Y long-term extension study).
• Mean change from baseline of mSASSS (average score from two selected readers, blinded for time order) for patients treated with Taltz for two years with data at both baseline and year 2 is presented (n=230; 54% of total randomized patients). Of the 657 patients who entered COAST-V or -W, 527 patients re-consented to enter COAST-Y; however, 104 patients had either baseline or Year 2 mSASSS data missing. Of 423 patients with baseline and Year 2 mSASSS data, 230 (54%) were treated with Taltz for at least two years. Of these, 110 were biologic-naïve and 120 were TNFi-experienced.

INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for the treatment of patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for the treatment of adults with active psoriatic arthritis, active ankylosing spondylitis, or active non-radiographic axial spondyloarthritis with objective signs of inflammation.

IMPORTANT SAFETY INFORMATION FOR TALTZ

CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group.  During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, oropharingeal pain and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis (also common). Adverse drug reactions in patients with radiographic axial spondyloarthritis (ankylosing spondylitis) were similar with the exception of inflammatory bowel disease (common) and rhinitis (common). In patients with non-radiographic axial spondyloarthritis, adverse events were also similar to  inflammatory bowel disease (common), influenza (common) and conjunctivitis (common).

Please see full Prescribing Information and Medication Guide for Taltz. See Instructions for Use included with the device.

IX HCP ISI 07MAY2020

About Taltz^® 
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.

About Axial Spondlyoarthritis
Axial spondyloarthritis (axSpA), which includes both radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA), is a disease predominantly affecting the sacroiliac joints and the spine. Common symptoms include chronic inflammatory back pain, fatigue and stiffness.^1,2,3 It is estimated that 2.3 million people in the U.S. have axSpA, and approximately half of those individuals live with nr-axSpA.^2,4 For patients with r-axSpA, the disease is characterized by the presence of structural damage of the sacroiliac joints that appears on an X-ray, while patients with nr-axSpA do not have clearly detectable structural damage radiographically.⁵ These two patient subsets share a similar burden of disease and similar clinical features, but approved biologic treatment options for patients with nr-axSpA are much more limited and patients are often underdiagnosed.^5,6

About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking, novel science to immunology and is driven to change what's possible for people living with autoimmune diseases. There are still significant unmet needs, as well as personal and societal costs, for people living with a variety of autoimmune diseases and our goal is to minimize the burden of disease. Lilly is investing in leading-edge clinical approaches across its immunology portfolio in hopes of transforming the autoimmune disease treatment experience. We've built a deep pipeline and are focused on advancing cutting edge science to find new treatments that offer meaningful improvements to support the people and the communities we serve.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/news. P-LLY

Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a treatment for ankylosing spondylitis, radiographic and non-radiographic axial spondylorarthritis, and psoriatric arthritis, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Taltz will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 

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