The Food and Drug Administration (FDA) has approved Taltz (ixekizumab; Lilly) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation.
The approval was based on data from the 52-week double-blind, placebo-controlled phase 3 COAST-X trial that evaluated the efficacy and safety of ixekizumab, a humanized interleukin-17A (IL-17A) antagonist, in patients aged ≥18 years with active nr-axSpA for at least 3 months. Patients were randomized to receive either placebo (n=105) or ixekizumab 80mg or 160mg at week 0, followed by either 80mg every 2 weeks (n=102) or 80mg every 4 weeks (n=96).
The primary end point was the proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at week 52. A key secondary end point was the ASAS40 response at week 16.
Results showed that the study met both primary and key secondary end points. Specifically, a greater proportion of patients treated with ixekizumab 80mg every 4 weeks achieved a statistically significant ASAS40 response at week 52 (30.2% vs 13.3%; P =.0045) and at week 16 (35.4% vs 19%; P =.0094) compared with placebo.
Additionally, health-related outcomes were assessed using the Short Form health survey (SF-36). Compared with placebo, patients treated with ixekizumab 80mg every 4 weeks showed greater improvement from baseline in the SF-36 physical component summary score and physical functioning, bodily pain, vitality, and social functioning domains at week 16. However, no consistent improvements in the mental component summary, role physical, general health, role emotional, and mental health domains were observed.
The safety profile of ixekizumab was consistent with that seen in previous studies. The most common treatment-emergent adverse events for ixekizumab were nasopharyngitis and injection site reaction.
“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. “Today’s FDA approval provides patients with a much-needed treatment option targeting IL-17A to improve the signs and symptoms of nr-axSpA.”
Taltz is already indicated for the treatment of active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. The product is supplied as 80mg of ixekizumab in single-dose prefilled autoinjectors and syringes.
The Company also offers a copay savings card to assist eligible patients.
For more information visit taltz.com.