TORONTO, Oct. 28, 2019 (GLOBE NEWSWIRE) -- Eli Lilly and Company announced that TALTZ met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis. The study demonstrated that 89 percent of patients treated with TALTZ achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score (PASI 75), and 81 percent of patients treated with TALTZ achieved a static Physician Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Results of the study were presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.
“Results from our study indicate that TALTZ may have the potential to clear skin and reduce itch in pediatric patients with moderate to severe plaque psoriasis,” said study investigator Kim Papp, MD, PhD, Probity Medical Research, Inc., Waterloo, Ontario, Canada. “While it is estimated that up to one third of people with psoriasis first develop symptoms during childhood, there are limited medications available for pediatric patients. This study provides encouraging data supporting the potential for TALTZ to become another treatment option for this patient population.”
The co-primary endpoints of the study were the proportion of patients achieving a significant 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children’s Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients ≥17 years old) at Week 12 was also evaluated.
“A child or adolescent with psoriasis can encounter significant barriers to their overall quality of life, impacting their self-esteem and ability to engage with friends and classmates," says Dr. Doron Sagman, Vice President, Medical Affairs, Lilly Canada. "We're pleased that the positive results produced in this study, strongly support TALTZ as an effective treatment option for the pediatric population living with moderate to severe psoriasis, pending regulatory approvals."
A total of 201 patients aged 6 to <18 years of age with moderate to severe plaque psoriasis were randomized to receive TALTZ (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001), including:
- 89 percent of patients treated with TALTZ achieved PASI 75 compared to 25 percent of patients treated with placebo.
- 81 percent of patients treated with TALTZ achieved sPGA 0,1 compared to 11 percent of patients treated with placebo.
TALTZ also met all major secondary endpoints in the study (P<0.001).
In this trial, the overall safety profile of TALTZ was consistent with previously reported results. The TALTZ safety profile has been studied across 15 clinical trials in plaque psoriasis and psoriatic arthritis, with 6,989 patients receiving TALTZ, with a total exposure of 16,586 patient-years (1,2,3).
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 (4). 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 (4).
About Moderate to Severe Plaque Psoriasis
Psoriasis is a chronic, immune disease that affects the skin (5). 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 (5,6). The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells (5). 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 (5).
About the Phase 3 Pediatric Study
This study is a Phase 3, multicenter, randomized, double-blinded, placebo controlled study to evaluate safety, tolerability and efficacy of TALTZ in patients from 6 to <18 years of age with moderate to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving at least a 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA 0 and PASI 100 at Week 12, and at least a four-point improvement in Itch numeric rating scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children’s Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients ≥17 years old) at Week 12 was also evaluated.
About Lilly in Dermatology
By following the science through unchartered territory, we continue Lilly’s legacy of delivering innovative medicines that address unmet needs and have significant impacts on people’s lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people’s lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.
About Eli 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.
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Media Contact:
Samira Rehman
Rehman_Samira@lilly.com
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REFERENCES
1 Data on file. Lilly USA, LLC. TAL20171211A.
2 Data on file. Lilly USA, LLC. DOF-IX-US-0019.
3 Mease P, Roussou E, Burmester GR, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials. Arth Care Res. 2018 (Epub). doi:10.1002/acr.23738.
4 TALTZ Product Monograph January 8, 2019.
5 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed September, 2019.
6 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.