by Drs. David Borenstein M.D. & C.H. Weaver M.D. 12/2018
Taltz (Ixekizumab) is a biologic, anti-IL-17A antibody that is approved by the US Food and Drug Administration (FDA) for the treatment of psoriasis and psoriatic arthritis. Clinical trial results published in Lancet for the pivotal phase 3 COAST-V clinical trial suggests Taltz will be an effective treatment option for ankylosing spondylitis (AS) and radiographic axial spondyloarthritis (AxSpA).
Biological disease-modifying anti-rheumatic drugs (bDMARDs) are recommended for radiographic axial spondyloarthritis, otherwise known as ankylosing spondylitis, when conventional therapies are not effective. Taltz is a high-affinity monoclonal antibody that selectively targets interleukin-17A (IL-17A), in patients with radiographic axial spondyloarthritis who have not previously been treated with bDMARDs.
The COAST-W clinical trial evaluated the effectiveness and safety of Taltz for the treatment of ankylosing spondylitis in difficult-to-treat patients who had failed one or two anti-tumor necrosis factor antibody therpies. The COAST-V clinical trial enrolled 341 patients with AS who were subsequently treated with Taltz, Adilumamab (ADA) or placebo (no treatment). Individuals response to treatment was assessed 16 weeks from the initiation of treatment. Individuals who participated in the study were on average 41 years of age and had AS an average of 16 years.
Overall 40% of Taltz treated patients experienced significant improvement in symptoms associated with active ankylosing spondylitis. Compared to placebo, Taltz was significantly better for controlling disease activity as measured by an improvement in spinal and sacroiliac joint inflammation, as well as an improving functional disability when compared to placebo. Both Taltz and ADA both worked well at controlling disease activity. No significant increase in adverse events like serious infections was noted.
The manufacturer of Taltz plans to apply for approval from the FDA sometime later this year. Targeting the IL-17 receptor appears to be an effective approach for treating ankylosing spondylitis; Cosentyx is another anti-IL-17 antibody that is effective in the treatment of ankylosing spondylitis and is already approved by the FDA for ankylosing spondylitis, psoriatic arthritis, and psoriasis.
- Van der Heijde et al. Ixekizumab significantly improves signs, symptoms, and spinal inflammation of active ankylosing spondylitis/radiographic axial spondyloarthritis:16-week results of a phase 3 randomized, active and placebo-controlled trial (abstract 1864) Arthritis Rheumatol 2018;70(suppl 10)