Taltz (ixekizumab) is a treatment approved by the U.S. Food and Drug Administration (FDA) for adults with active ankylosing spondylitis (AS). Developed by Eli Lilly and Company, it is designed to help alleviate arthritic pain and stiffness caused by inflammation.
How does Taltz work?
AS is a form of chronic arthritis that is characterized by inflammation, pain, and stiffness in the spine, shoulders, hips, ribs, heels, small joints of the hands and feet, and eyes.
The active ingredient in Taltz is a monoclonal antibody that selectively binds to a pro-inflammatory cytokine (a cell-signaling molecule that promotes inflammation) called IL-17A. By decreasing IL-17A-directed inflammation, Taltz can significantly reduce AS symptoms, such as morning stiffness, spine or back pain, and fatigue.
Taltz in clinical trials
Two concurrent randomized, double-blind, controlled clinical trials called COAST-V (NCT02696785) and COAST-W (NCT02696798) were conducted to determine the safety and efficacy of Taltz in AS patients.
In the COAST-V study, 341 patients — who had not been previously treated with agents that affect the immune system — were randomized to receive under-the-skin injections of 80 mg of Taltz every two weeks, 80 mg of Taltz every four weeks, 40 mg of Humira every two weeks (as a positive control), or a placebo every two weeks (as a negative control).
In the COAST-W study, 316 patients — who had previously been treated unsuccessfully with one or more inhibitors of a pro-inflammatory cell-signaling molecule called TNFα — were randomized to receive under-the-skin injections of 80 mg of Taltz every two weeks, 80 mg of Taltz every four weeks, or a placebo every two weeks.
The primary objective of both studies was the proportion of patients who responded and showed significant improvements in disease symptoms upon treatment with Taltz when analyzed over a period of 16 weeks. Patients were assessed using the spondyloarthritis international society-40 (ASAS40) improvement criteria.
The results of the study were published in the Rheumatology and Therapy journal and showed that patients treated with Taltz in both COAST-V and COAST-W trials showed significant improvements in all the four domains assessed by the ASAS40 improvement criteria compared with the placebo-treated controls.
Patients treated with Taltz in the COAST-V trial showed a 2.6- to 5.3-fold improvement in pain, fatigue, sleep, and quality of life, and those treated with Taltz in the COAST-W trial showed a 5.1- to 18.5-fold greater improvement in these parameters compared with the controls.
Taltz was approved by the FDA for the treatment of adults with moderate or severe plaque psoriasis in March 2016, and for the treatment of adults with active psoriatic arthritis in December 2017.
Taltz should not be used by patients who have previously reported hypersensitivity reactions. Moreover, because Taltz can increase the risk of infections because it blocks an important arm of the immune response, patients need to be evaluated for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations before starting the treatment.
Last updated Sept. 12, 2019
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