FDA Approves Ixekizumab for Ankylosing Spondylitis

August 30, 2019

Lilly has announced that it received FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis).

Lilly has announced that it received FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis).

Ixekizumab is an IL-17 inhibitor currently approved as treatment for patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for patients with active psoriatic arthritis. There are a number of biologics approved for the treatment of ankylosing spondylitis, including adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi, Simponi Aria), and infliximab (Remicade).

Ixekizumab for active ankylosing spondylitis was approved as an injection of 80 mg/mL strictly for adult patients with this condition. It can be administered as monotherapy or as a combination treatment with conventional DMARDs or NSAIDs.

Ixekizumab is currently approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and for the treatment of adults with active psoriatic arthritis. 

The efficacy and safety of ixekizumabin for ankylosing spondylitis was demonstrated in two randomized, double-blind, placebo-controlled phase three trials of 657 patients who had never before been treated with a biologic and who had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors. The primary endpoint was determined as ASAS40 at 16 weeks, in which a proportation of patients met. It was the first trial (called "COAST") in which the primary endpoint was made.

The response rates were as follows:

  • COAST-V: 48 percent of patients treated with Taltz every four weeks versus 18 percent of patients treated with placebo (p<0.0001)

  • COAST-W: 25 percent of patients treated with Taltz every four weeks versus 13 percent of patients treated with placebo (p<0.05)

  • Patients treated with Taltz also 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 (p=0.0015)

  • COAST-W: 48 percent of patients treated with Taltz every four weeks versus 30 percent of patients treated with placebo (p<0.01)

  • Overall, the safety profile observed in patients with AS treated with Taltz is consistent with the safety profile in patients with psoriasis.

"Results from the phase three clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors," said Philip Mease, M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington in a statement issued by Lilly. "This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of ankylosing spondylitis."