New Head-to-Head Data Show Taltz® (ixekizumab) Superiority versus TREMFYA® (guselkumab) in People with Moderate to Severe Plaque Psoriasis

-Taltz met the primary endpoint of the IXORA-R study, with 41.3 percent of patients taking Taltz achieving complete skin clearance as measured by PASI 100 at Week 12 versus 24.9 percent of patients taking TREMFYA

-Taltz also met all major secondary endpoints up to Week 12

INDIANAPOLIS, IN, USA I October 3, 2019 I Eli Lilly and Company (NYSE: LLY) today presented detailed data at the 5th Annual Maui Derm NP+PA Fall meeting from the Phase 4 IXORA-R study, the first head-to-head (H2H) study between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint. Taltz met the primary endpoint of superiority vs. TREMFYA in the proportion of patients with moderate to severe plaque psoriasis achieving complete skin clearance as measured by PASI 100 at Week 12, as well as key secondary endpoints. The study is ongoing through Week 24.

"Healthcare providers and patients value speed of response when evaluating treatment options for moderate to severe plaque psoriasis," said lead study investigator Andrew Blauvelt, M.D., M.B.A., dermatologist and president of Oregon Medical Research Center in Portland, OR. "The results from the IXORA-R study demonstrate that Taltz was effective in helping more patients achieve completely clear skin by Week 12, with a 50 percent improvement in skin plaques seen as early as Week 1."

The primary endpoint of the study was superiority for Taltz compared to TREMFYA in the proportion of patients achieving complete skin clearance as measured by PASI 100 at Week 12. Key secondary endpoints included superiority over TREMFYA in the proportion of patients achieving PASI 75 at Week 2, PASI 90 at Weeks 4 and 8, PASI 100 at Weeks 4, 8 and 24, static Physician's Global Assessment (sPGA) 0 at Week 12 and PASI 50 at Week 1.

Patients treated with Taltz demonstrated statistically significantly higher improvements than those treated with TREMFYA as measured by PASI 100 at Week 12 (41.3 percent versus 24.9 percent, P<0.001). Additionally, all major secondary endpoints up to Week 12 were achieved (P<0.001).

"As new medicines become available for people living with psoriasis, there's an increasing need to directly compare the efficacy and safety of these treatments to help healthcare providers and patients make informed treatment decisions," said Rhonda Pacheco, Pharm.D., global brand development leader for immunology at Lilly. "These results demonstrate that Taltz can provide high levels of skin clearance early in treatment for people with psoriasis."

A total of 1,027 patients with moderate to severe plaque psoriasis were enrolled in the study to evaluate the efficacy and safety of Taltz compared to TREMFYA. Participants were randomized to receive Taltz or TREMFYA at the approved dose for a total of 24 weeks, with the primary analysis conducted at 12 weeks.

In IXORA-R, the safety profiles of Taltz and TREMFYA were consistent with those previously reported for both treatments. As the IXORA-R study is ongoing, not all data will be presented at this meeting to prevent unblinding for investigators and participants. Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020.

INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.

About Taltz®
Taltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1 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.1

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. Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate to severe plaque psoriasis.1,3 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.1 Patients with plaque psoriasis often have other serious health conditions, such as diabetes and heart disease and experience negative impact on their quality of life.1

About the IXORA-R Study
IXORA-R is a Phase 4, multicenter, randomized, blinded, parallel-group study comparing the efficacy and safety of Taltz versus TREMFYA in people living with moderate to severe plaque psoriasis. The primary endpoint of the study was the proportion of patients achieving PASI 100 response at Week 12. The major secondary endpoints include the proportion of patients achieving PASI 75 at Week 2, PASI 90 at Weeks 4 and 8, PASI 100 at Weeks 4, 8 and 24, static Physician's Global Assessment (sPGA) 0 at Week 12 and PASI 50 at Week 1.

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 our 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/newsroom.  P-LLY

1 Taltz Prescribing Information, 2019.
2 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed September, 2019.
3 Skin conditions by the numbers. American Academy of Dermatology website. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed September, 2019.

SOURCE: Eli Lilly

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