Lilly's Taltz Achieves Phase 3 Clinical Trial Success with 81% of Pediatric Patients Achieving Clear or Almost Clear Skin in Moderate-to-Severe Plaque Psoriasis

Recently, at the 28th Congress of the European Academy of Dermatology and Venereology (EADV), Eli Lilly and Company announced that its IL-17A inhibitor Taltz (ixekizumab) met the primary endpoint and all key secondary endpoints in a Phase 3 trial involving patients aged 6 to 18 years with moderate-to-severe plaque psoriasis. Taltz is currently the first and only IL-17A inhibitor to report positive results in this patient population. These positive trial outcomes will support Eli Lilly’s submission of a new drug application to the FDA for this indication.

Plaque psoriasis is an autoimmune disease characterized by well-demarcated, pale red or purplish-brown plaques ranging in size from coins to palms, with variable numbers and covered by fine, thin scales. Plaque psoriasis is the most common form of psoriasis. Psoriasis is a skin condition that causes redness and scaling, and it is more prevalent among individuals with a family history of the disease. Globally, this condition affects 125 million people, 20% of whom have moderate-to-severe plaque psoriasis.

Taltz is an IL-17A monoclonal antibody developed by Eli Lilly and Company. IL-17A is a pro-inflammatory cytokine. By binding to IL-17A, Taltz reduces inflammation levels, thereby alleviating patient symptoms. Previously, it has received FDA approval for the treatment of psoriasis and psoriatic arthritis (PsA).

A total of 201 patients aged 6 to under 18 years with moderate-to-severe plaque psoriasis participated in this randomized, double-blind, placebo-controlled Phase 3 clinical study. The trial results demonstrated that at Week 12, the proportion of patients treated with Taltz who achieved a ≥75% reduction in the Psoriasis Area and Severity Index (PASI 75) was significantly higher than that in the control group (89% vs. 25%). Furthermore, 81% of patients in the treatment group achieved clear or almost clear skin as defined by a Physician’s Global Assessment (PGA) score of 0 or 1, compared with only 11% in the placebo group, thereby meeting the primary endpoint of the study. In addition, key secondary endpoints were also met, including PASI 90, PASI 100, static PGA (sPGA) 0, and meaningful improvement as measured by the Itch Numerical Rating Scale (Itch NRS).

“Psoriasis has a profound impact on children and adolescents, affecting not only their self-esteem but also their ability to interact with peers,” said Dr. Lotus Mallbris, Vice President of Immunology Development at Eli Lilly and Company. “We are pleased to see the positive results of Taltz in treating pediatric and adolescent patients. This trial confirms the therapeutic potential of Taltz in patients aged 6 to under 18 years, and we look forward to working with regulatory authorities to advance the approval of this therapy.”

References:

[1] Lilly Presents Positive Results for Taltz® (ixekizumab) in Pediatric Patients with Moderate to Severe Plaque Psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress, Retrieved October 14, 2019, from https://investor.lilly.com/news-releases/news-release-details/lilly-presents-positive-results-taltzr-ixekizumab-pediatric

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