General Information

Taltz (ixekizumab) is a humanized interleukin-17A antagonist. 

Taltz is specifically indicated for the treatment of adult patients with active ankylosing spondylitis.

Taltz is specifically indicated for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation.

Taltz is supplied as a solution for subcutaneous injection. The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. cDMARDs (e.g., sulfasalazine), corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be used during treatment with Taltz.

Clinical Results

FDA Approval

The FDA approval of Taltz for Ankylosing Spondylitis was based on two randomized, double-blind, placebo-controlled Phase 3 studies that included 657 adult patients with active AS: COAST-V in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve and COAST-W in patients who previously had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors.

In both studies, the primary efficacy endpoint was the proportion of patients at 16 weeks achieving Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo. ASAS40 measures disease signs and symptoms such as pain, inflammation and function. Results from both studies demonstrated that patients treated with Taltz achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by ASAS40 response, compared to placebo. At 16 weeks, patients achieved ASAS40 at the following response rates:

• COAST-V: 48 percent of patients treated with Taltz every four weeks versus 18 percent of patients treated with placebo
• COAST-W: 25 percent of patients treated with Taltz every four weeks versus 13 percent of patients treated with placebo

Additionally, patients treated with Taltz demonstrated statistically significant improvements in key secondary endpoints in both studies, including the proportion of patients at 16 weeks achieving ASAS20 at the following response rates:

• COAST-V: 64 percent of patients treated with Taltz every four weeks versus 40 percent of patients treated with placebo
• COAST-W: 48 percent of patients treated with Taltz every four weeks versus 30 percent of patients treated with placebo

The FDA Approval of Taltz for nr-axSpA was based on the results from the Phase 3, multicenter, randomized, double-blind, placebo-controlled 52-week study of adult patients with active nr-axSpA with objective signs of inflammation. The primary endpoint of the study was the proportion of patients achieving ASAS40 at Week 52. The proportion of Taltz patients (n=96) achieving the primary endpoint was superior to placebo (n=105), with 30 percent of patients treated with Taltz 80 mg every four weeks achieving ASAS40 response compared to 13 percent of patients treated with placebo at Week 52. A major secondary endpoint was ASAS40 response at Week 16, with 35 percent of Taltz patients reaching that endpoint compared to 19 percent of placebo patients.

Side Effects

Adverse effects associated with the use of Taltz may include, but are not limited to, the following:

injection site reactions

upper respiratory tract infections

nausea

tinea infections

Taltz should not be used in patients with a previous serious hypersensitivity, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations.

Mechanism of Action

Taltz (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.

Additional Information

For additional information regarding Taltz or active ankylosing spondylitis, please visit the Taltz web page.