Lilly Announces Positive Phase 3 Results for Taltz (ixekizumab) in Non-Radiographic Axial Spondyloarthritis

COAST-X is a multicenter, randomized, double-blind, placebo-controlled, 52-week study evaluating the efficacy and safety of Taltz in patients with non-radiographic axial spondyloarthritis (nr-axSpA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARDs). The primary endpoint was the Assessment of SpondyloArthritis international Society 40% improvement response (ASAS40).

The results showed that Taltz met the primary endpoint at both Week 16 and Week 52, as assessed by the proportion of patients achieving ASAS40 response, demonstrating statistically significant improvements in the signs and symptoms of nr-axSpA compared with placebo. Furthermore, Taltz also met key secondary endpoints at Weeks 16 and 52, including: significant improvement in the Ankylosing Spondylitis Disease Activity Score (ASDAS); significant improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); increased proportion of patients achieving low disease activity (ASDAS <2.1); significant improvement in sacroiliitis (assessed by MRI at Week 16); and significant improvement in the Physical Component Summary (PCS) score of the 36-Item Short Form Health Survey (SF-36). The safety profile of Taltz in this study was consistent with that reported in previous Phase III studies, with no new safety signals identified.

Eli Lilly plans to hold a scientific conference later this year.ConferenceDetailed results of the COAST-X study were published. Based on these positive data,Eli LillyRegulatory submissions for Taltz in the treatment of nr-axSpA are planned for 2019. Currently, the application for Taltz in the treatment of axSpA is under review by the U.S.FDAreview, with the results expected to be received later this year.

Atul Deodhar, M.D., Professor of Medicine at Oregon Health & Science University and Clinical Investigator for the COAST-X program, stated, “nr-axSpA’sDiagnosis“It is highly challenging, as it is often missed in clinical practice, and treatment options available to physicians for these patients are limited. The results of the COAST-X study provide compelling evidence that Taltz can offer a much-needed new alternative for this patient population.”

Eli LillyChristi Shaw, President of Biopharmaceuticals, stated, “The results from the COAST-X study are encouraging and support our belief that Taltz has the potential to become the first IL-17A antagonist approved in the United States for patients with nr-axSpA. The COAST-X data add to the growing body of evidence from our COAST program, suggesting that Taltz may be effective across the entire axSpA disease spectrum.”

Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease that primarily affects the sacroiliac joints and axial skeleton, with an estimated 4.5 million adults affected worldwide. axSpA is considered a single disease entity, divided into patient subgroups defined by radiographic structural damage in the sacroiliac joints (radiographic axSpA or ankylosing spondylitis [AS]) and those without evident structural damage (nr-axSpA). These two patient subgroups exhibit similar disease burdens and comparable clinical features, such as spinal inflammation and chronic inflammatory back pain.

The COAST-X study is part of the COAST clinical development program, which aims to evaluate the efficacy and safety of Taltz in patients with different subgroups of axial spondyloarthritis (axSpA). The COAST program includes three registration studies, each lasting one year: COAST-V was conducted in patients with ankylosing spondylitis (AS)/radiographic axSpA who were naive to biologic disease-modifying antirheumatic drugs (bDMARDs); COAST-W was conducted in patients with AS/radiographic axSpA who were intolerant to or had an inadequate response to tumor necrosis factor (TNF) inhibitors; and COAST-X was conducted in patients with non-radiographic axSpA (nr-axSpA) who were naive to bDMARDs. Upon completion of these registration studies, patients may enroll in a long-term extension study (COAST-Y) to receive an additional two years of treatment with Taltz. Results from the COAST-V and COAST-W studies were published in 2018.

Taltz isEli LillyA novel anti-inflammatory drug has been developed, with ixekizumab as its active pharmaceutical ingredient. Ixekizumab is a monoclonal antibody that exhibits high affinity and specificity for the pro-inflammatory cytokine interleukin-17A (IL-17A), thereby inhibiting the binding of IL-17A to the IL-17 receptor. Ixekizumab does not bind to the cytokines IL-17B, IL-17C, IL-17D, IL-17E, or IL-17F. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. In patients with psoriasis, IL-17A plays a critical role in driving the hyperproliferation and activation of keratinocytes (skin cells).

Taltz is administered via subcutaneous injection. In the U.S. market, the drug was first approved in March 2016, becoming the secondNovartisThe Second IL-17A Inhibitor Approved in the U.S. After the Blockbuster Anti-Inflammatory Drug Cosentyx (secukinumab)Monoclonal antibody drugsCurrently, the approved indications for Taltz include: (1) treatment of adult patients with active psoriatic arthritis (PsA); (2) treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The industry holds a highly optimistic view of Taltz’s commercial prospects. Pharmaceutical market research firm Evaluate previously released a report predicting that Taltz’s sales would reach $2.707 billion in 2024. (Bioon.com)

Original source:Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz? (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis