NICE Recommends Lilly's IL-17A Inhibitor Taltz for Axial Spondyloarthritis

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The UK's National Institute for Health and Care Excellence (NICE) recently issued a Final Appraisal Document (FAD) recommending Eli Lilly's anti-inflammatory drug Taltz (ixekizumab) for the treatment of active axial spondyloarthritis (axSpA). Specifically, it is recommended for patients with axSpA inadequately controlled with conventional therapy, or for patients with active non-radiographic axial spondyloarthritis (nr-axSpA) inadequately controlled with nonsteroidal anti-inflammatory drugs (NSAIDs) who exhibit objective signs of inflammation.

NICE only recommends the use of Taltz when tumour necrosis factor (TNF) inhibitors are unsuitable or do not adequately control the disease.

The primary clinical evidence supporting this recommendation is derived from three placebo-controlled randomized clinical trials (COAST-V, COAST-W, and COAST-X), which enrolled patients with an inadequate response to or intolerance of NSAIDs and evaluated the efficacy and safety of Taltz in the treatment of radiographic and non-radiographic axSpA.

In these trials, patients treated with Taltz demonstrated statistically and clinically significant improvements in axSpA symptoms and signs compared with placebo. At Week 16, a higher proportion of patients in the Taltz treatment group achieved an Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) response.

NICE also utilized direct evidence from the COAST trial to determine the cost-effectiveness estimate of Taltz compared with conventional therapy, which falls within the range typically considered by the agency to represent a cost-effective use of NHS resources.

Jyun Yan Yang, Senior Medical Lead for the UK and Nordics at Eli Lilly and Company, said: “Many patients with axSpA experience chronic back pain and associated functional impairment, which adversely affects their quality of life. We are pleased that NICE has recommended Taltz as a new treatment option for these patients.”

axSpA is a disease that primarily affects the sacroiliac joints and spine, leading to chronic inflammatory back pain and fatigue. axSpA is classified into radiographic axSpA (r-axSpA, also known as "ankylosing spondylitis, AS") and non-radiographic axSpA (nr-axSpA).

Taltz is an IL-17A inhibitor, a monoclonal antibody that selectively binds to the cytokine interleukin-17A (IL-17A) and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Taltz inhibits the release of proinflammatory cytokines and chemokines.

To date, Taltz has been approved for four indications: (1) plaque psoriasis (pediatric patients aged 6 years and older and adult patients); (2) psoriatic arthritis (adult patients); (3) AS (adult patients); (4) nr-axSpA (adult patients).

Reference: NICE backs Lilly’s Taltz for axial spondyloarthritis