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Taltz Approved to Treat AS

Last week, the United States Food and Drug Administration (US FDA) announced that Taltz (ixekizumab) has been approved for the treatment of active ankylosing spondylitis (or radiographic axial spondyloarthritis) in adults. Previously, Taltz was approved for adults with moderate-to-severe plaque psoriasis. It was also approved for adults with active psoriatic arthritis. This new approval will expand the label for Taltz, and allow it to be used in AS, in addition to the other conditions it may be prescribed for.

What is Taltz?

Taltz belongs to a treatment class called biologics (or biologic medications) and is an IL-17A-targeting antibody. This means that it finds, attaches to, and blocks the action of interleukin 17A (IL-17A). IL-17A is a cytokine. Cytokines are messengers in the immune system that play a role in the immune system response. IL-17A is a pro-inflammatory cytokine, meaning it increases inflammation in the body, which may play a role in the development and progression of AS-related symptoms. By blocking IL-17A with Taltz, the immune response and inflammation may be toned down to alleviate symptoms or prevent further damage from AS.

Why was Taltz approved?

This approval was granted after the review of results published from two clinical trials called the COAST-V and COAST-W trials. Together, these trials included over 650 adults with active AS. The COAST-V trial included only individuals who had never received biologic medications in the past, whereas the COAST-W trial included individuals who had previously tried TNF inhibitors (a type of biologic medication) but had minimal to no response.

In both trials, Taltz was found to provide significantly and clinically meaningful improvements in individuals with active AS over the course of four months when compared to placebo (individuals who did not receive Taltz). AS-related improvements were measured using the Assessment of Spondyloarthritis International Society 40 (ASAS40), a measurement tool that assesses pain, function, inflammation, and other signs of AS. There were no differences found for the safety of Taltz used for AS when compared to Taltz used for other already approved indications, like psoriasis.

How should Taltz be taken?

The currently approved dose of Taltz is 80 mg/mL and is administered as an injection. It may be used on its own or with other medications including corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or conventional disease-modifying antirheumatic drugs (DMARDs). Since Taltz impacts the immune system, it may increase an individual’s risk of infection. Before starting Taltz, individuals may be tested for tuberculosis (TB). The most common side effects of Taltz include, but may not be limited to: nausea, injection site reactions, upper respiratory infections, and certain fungal infections.1

  1. Lilly Receives U.S. FDA Approval for Taltz® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis). Eli Lilly & Company. https://investor.lilly.com/news-releases/news-release-details/lilly-receives-us-fda-approval-taltzr-ixekizumab-treatment. Published August 26, 2019. Accessed August 31, 2019.

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