Lilly announces superiority of TALTZ® (ixekizumab) versus TREMFYA® (guselkumab) in delivering total skin clearance at week 12 in topline results from head-to-head (IXORA-R) trial in people living with moderate to severe plaque psoriasis
IXORA-R is the first Phase 4, head-to-head study comparing efficacy between the IL-17A inhibitor TALTZ and the IL-23/p19 inhibitor TREMFYA using PASI 100 as the primary endpoint
TORONTO, ON – August 14, 2019 - Eli Lilly and Company announced yesterday that TALTZ® (ixekizumab) met the primary and all major secondary endpoints in the Phase 4 IXORA-R study, which evaluated the efficacy and safety of TALTZ versus TREMFYA® (guselkumab) in people living with moderate to severe plaque psoriasis (PsO). The IXORA-R trial is the first completed head-to-head (H2H) trial between an IL-17A inhibitor and IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint.
At 12 weeks, TALTZ met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100. In addition, TALTZ met the major secondary endpoints, which include 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 and 8, static Physician Global Assessment (sPGA) 0 at Week 12 and PASI 50 at Week 1. Lilly plans to share results on the remaining secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020.
“Lilly is listening to patients. This data offers much optimism to patients living with moderate to severe plaque psoriasis, and who have long vocalized their need for treatment that can completely clear skin with proven rapidity,” says Dr. Ron Vender MD FRCPC, Dermatologist, Director of Dermatrials Research Inc. and Associate Clinical Professor of Medicine, McMaster University. “This is the type of data we have been asking for to help us make informed treatment recommendations for our patients.”
There were 1,027 patients with moderate to severe plaque psoriasis enrolled in the study to evaluate the efficacy and safety of TALTZ compared to TREMFYA. Participants were randomized to receive TALTZ (160 mg at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks) or TREMFYA (100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter) for 24 weeks total, with the primary analysis conducted at 12 weeks.
“Research has shown that patients want to see their skin clearing up quickly, and we are pleased that the results of the IXORA-R clinical trial demonstrate that TALTZ meets that need,” says Doron Sagman, Vice President, Medical Affairs, Lilly Canada. “Immunology continues to be a major focus at Lilly and we are confident that the results of this trial have further anchored the significance of TALTZ for patients with moderate to severe plaque psoriasis.”
In IXORA-R, the safety profile of TALTZ was consistent with previously reported results. No new safety signals were detected.
Lilly plans to submit detailed data from the IXORA-R study for disclosure at scientific meetings and in peer-reviewed journals.
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 of PASI 100 response at Week 12. The major secondary endpoints include the proportion of patients achieving PASI 50 as at week 1; PASI 75 at week 2; PASI 90 at weeks 4 and 8; and PASI 100 at weeks 4, 8 and 24; as well as the proportion of patients achieving a static Physician Global Assessment (sPGA) score of 0 at week 12.
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.
TALTZ Product Monograph, revised January 8, 2019. http://pi.lilly.com/ca/TALTZ-ca-pm.pdf
Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed July, 2019.
Skin conditions by the numbers. American Academy of Dermatology website. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed July, 2019.