Studies Demonstrate Lilly's Taltz® (ixekizumab) Maintained or Achieved High Levels of Skin Clearance for Patients with Moderate-to-Severe Plaque Psoriasis through 60 Weeks: Results Published in the New England Journal of Medicine

INDIANAPOLIS, June 8, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the New England Journal of Medicine has published detailed results from three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—that demonstrated the efficacy and safety of Taltz^® (ixekizumab) through 60 weeks in patients with moderate-to-severe plaque psoriasis. This publication also detailed 12-week efficacy data for patients treated with Taltz in UNCOVER-1.

In all three studies, responders to Taltz through 12 weeks demonstrated high levels of skin clearance through 60 weeks.

"This group of studies show that patients on Taltz are able to achieve high levels of efficacy, and that the majority of patients are able to maintain or continue to improve their response with continued treatment through 60 weeks," said Kenneth Gordon, M.D., a professor of dermatology at Northwestern University Feinberg School of Medicine and first author of the paper.

STUDY DESIGNS
All three studies evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks. All three studies also evaluated response rates with Taltz every four weeks through 60 weeks. In UNCOVER-1 and UNCOVER-2, patients treated with Taltz who achieved clinical response (static Physician's Global Assessment score [sPGA] 0 or 1) at 12 weeks were re-randomized to receive Taltz (80 mg every four weeks) or placebo through 60 weeks. In UNCOVER-3, all patients completing 12 weeks continued the study receiving Taltz (80 mg every four weeks) through 60 weeks.

In all three studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index score (PASI) 75 and sPGA 0 or 1. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a recommended measure the FDA uses to evaluate effectiveness.¹ In all three studies, sPGA and PASI were also assessed through 60 weeks.

RESULTS
In UNCOVER-1, Taltz given every two weeks was statistically superior to placebo, with high levels of clearance achieved at 12 weeks among patients treated with Taltz, the majority of whom achieved virtually clear (PASI 90) or completely clear skin (PASI 100, sPGA 0).

• 81.8 percent of patients treated with Taltz achieved sPGA 0 or 1 compared to 3.2 percent of those treated with placebo (p<0.001).
• 89.1 percent of patients treated with Taltz achieved PASI 75 compared to 3.9 percent of patients treated with placebo (p<0.001).
• 70.9 percent of patients treated with Taltz achieved PASI 90 compared to 0.5 percent treated with placebo (p<0.001).
• 35.3 percent of patients treated with Taltz achieved complete resolution of psoriasis plaques (PASI 100) compared to zero patients treated with placebo (p<0.001).

In UNCOVER-1 and UNCOVER-2, high levels of clearance also were achieved through 60 weeks among patients treated with Taltz every two weeks who achieved clinically meaningful response (sPGA 0 or 1) at 12 weeks, the majority of whom achieved virtually clear or completely clear skin through 60 weeks when treated with Taltz every four weeks. 

In UNCOVER-1 and UNCOVER-2 through 60 weeks:

• 78.3 percent of patients maintained sPGA 0 or 1.
• 83.3 percent of patients achieved PASI 75.
• 76.5 percent of patients achieved PASI 90.
• More than half of patients (57.5 percent) achieved complete resolution of skin plaques (PASI 100).

In UNCOVER-3, high levels of clearance were also achieved with Taltz given every four weeks through 60 weeks among patients initially treated with Taltz every two weeks:

• 74.5 percent of patients achieved sPGA 0 or 1.
• 83.4 percent of patients achieved PASI 75.
• 73.2 percent of patients achieved PASI 90.
• More than half of patients (55.3 percent) achieved complete resolution of skin plaques (PASI 100).

"Over the last several years, advances in our understanding of psoriasis have led to the development of new treatment targets that may provide higher levels of skin clearance," said Aarti Shah, Lilly's global brand development leader for Taltz. "The results of these analyses are significant, demonstrating that the majority of patients treated with Taltz through 60 weeks achieved or maintained virtually or completely clear skin."

Information regarding the safety of Taltz is drawn from a database of 4,204 patients with moderate-to-severe plaque psoriasis who volunteered in both controlled and uncontrolled clinical trials.

Taltz may increase the risk of infection. Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. 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.

Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. See Important Safety Information below.

Results from 12-week data in UNCOVER-2 and UNCOVER-3 were published in The Lancet in June 2015. Results from the UNCOVER-3 long-term extension study were also recently presented at the American Academy of Dermatology (AAD) Annual Meeting, March 4-8, 2016.

Indications and Usage
Taltz^® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

IMPORTANT SAFETY INFORMATION

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. The Taltz group had a higher rate of infections than the placebo group (27% vs. 23%). 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. Patients receiving Taltz should be monitored closely 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. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease
Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.

Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.

ADVERSE REACTIONS
Most common adverse reactions (>1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.  

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 22MAR2016

About Taltz^®
Taltz^® (ixekizumab) is a humanized IgG4 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. Taltz was approved by the U.S. Food and Drug Administration (FDA) in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

About the UNCOVER Studies
The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicenter, Phase 3 studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries. All three studies evaluated the safety and efficacy of different dosing regimens of Taltz (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received U.S.-approved etanercept (50 mg twice a week) for 12 weeks. In all three studies, safety and efficacy of Taltz was further evaluated through 60 weeks.

About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, immune disease that affects the skin.² It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.² It is the most common inflammatory disease in the United States, affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.² The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.² Approximately 20 percent of people with psoriasis have moderate-to-severe plaque psoriasis.³

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to 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 www.lilly.com and http://newsroom.lilly.com/social-channels. P-LLY

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 moderate-to-severe plaque psoriasis, and reflects Lilly's current belief. 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.

¹ Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64:ii65-ii68. http://ard.bmj.com/content/64/suppl_2/ii65.full. Accessed April 13, 2016.
² Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed April 13, 2016.
³ Psoriasis. American Academy of Dermatology website. https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis. Accessed April 13, 2016.

Refer to:  J. Scott MacGregor; [email protected]; 317-440-4699  

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