FDA Approves Ixekizumab for Non-radiographic Axial Spondyloarthritis

Officials with the FDA have approved ixekizumab (Taltz, Eli Lilly) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation, according to a press release. 

With this new indication, ixekizumab is the first interleukin-17A (IL-17A) antagonist to be approved by the FDA for nr-axSpA. 

The approval of this supplemental New Drug Application is based on results from the phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria compared with placebo. 

According to the data, the proportion of ixekizumab-treated patients (n=96) who achieved ASAS40 at week 52, which was the primary end point, was superior to placebo (n=105), with 30% of patients treated with ixekizumab 80 mg every 4 weeks achieving ASAS40 response compared with 13% of patients treated with placebo at week 52 (P=0.0045). At week 16, 35% of ixekizumab-treated patients compared with 13% of placebo-treated patients achieved the ASAS40 response, a major secondary end point, the study showed. 

Related: FDA OKs Ixekizumab for Pediatric Patients With Plaque Psoriasis

Other major secondary end points of the study included Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity (BASDAI), the proportion of patients achieving low disease activity (ASDAS <2.1) and the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score. 

The safety profile of ixekizumab in patients with nr-axSpA was consistent with previous experience with ixekizumab in other approved indications.

“In the COAST-X study, Taltz provided relief to nr-axSpA patients living with debilitating symptoms such as chronic back pain and fatigue,” said Atul Deodhar, MD, professor of medicine, Oregon Health & Science University and clinical investigator for the COAST pivotal trial program. “The study results indicate that Taltz is safe and effective in patients suffering from this condition. Today’s FDA approval provides patients with a much-needed treatment option targeting IL-17A to improve the signs and symptoms of nr-axSpA.”

Ixekizumab is also approved for the treatment of active psoriatic arthritis, or active ankylosing spondylitis, and for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

References:

1. Lilly’s Taltz (ixekizumab) is the First IL-17A Antagonist to Receive US FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA). Eli Lilly. News Release; June 1, 2020. Accessed June 3, 2020.