TORONTO, Oct. 10, 2019 (GLOBE NEWSWIRE) — Eli Lilly and Company 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 all key secondary endpoints. The study is ongoing through Week 24.
“With TALTZ, more patients achieved completely clear skin by Week 12, with a PASI 50 superiority endpoint achieved as early as Week 1,” says Dr. Kim Papp, MD, PhD, FRCPC. “Given this rapid onset of efficacy, TALTZ is clearly an important treatment option for patients with moderate to severe plaque psoriasis.”
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 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).
“In order for healthcare providers to make appropriate treatment decisions within a growing array of treatment options, studies like IXORA-R are critical,” says Dr. Doron Sagman, Vice President, Medical Affairs, Lilly Canada. “TALTZ demonstrated superiority in clinically meaningful skin clearance outcomes at both week 12 in the primary analysis of the study, as well as in secondary analyses at earlier time points.”
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.
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 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 Lilly Canada
Eli Lilly and Company 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 Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
1 TALTZ Product Monograph, revised January 8, 2019. http://pi.lilly.com/ca/TALTZ-ca-pm.pdf
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-numbers. Accessed September, 2019.