Taltz Receives New Indication for Ankylosing Spondylitis

August 26, 2019 – The U.S. FDA has approved a new indication for Taltz® (ixekizumab), manufactured by Eli Lilly. The product is now indicated to treat adult patients who have active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).

Affecting an estimated 1.6 million people in the United States, AS is a form of chronic inflammatory arthritis that primarily affects the spine. Like other forms of arthritis, the condition can lead to inflammation, pain, stiffness, and loss of mobility. Other regions of the body can be affected, including the shoulders, ribs, hips, heels, and small joints of the hands and feet. In some cases, AS may even affect the eyes, lung, and heart. The primary feature of AS is the involvement of the sacroiliac (SI) joints, which are found where the spine joins the pelvis.

Patients treated with Taltz in a clinical study achieved statistically significant and clinically meaningful improvements in signs and symptoms compared to placebo. The study measured the percentage of patients who achieved ASAS40, a standardized measurement of improvement form baseline. Each patient was assigned to one of two groups – patients who were treatment naïve with biologic disease-modifying antirheumatic drugs (bDMARDs), and patients who had previously had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors. Almost half (48%) of bDMARD-naïve patients who received Taltz achieved an ASAS40 response by week 16, compared to 18% of patients who received placebo. Amongst patients who had not seen success on TNF inhibitors, 25% treated with Taltz achieved ASAS40 by week 16, compared to 13% on placebo.

Recommended dosing under the new indication is 160mg given once in the first week via two 80mg subcutaneous (SC) injections. This is followed by a single 80mg injection once every four weeks.

Originally FDA approved in 2016, Taltz is also indicated to treat active psoriatic arthritis, in addition to moderate-to-severe plaque psoriasis.