“Ankylosing spondylitis is a chronic and debilitating disease, and I have a large number of patients who have failed TNF inhibitors,” says Dr. Atul Deodhar from Oregon Health and Science University, Portland.
“There’s a need for more options, specifically for this difficult-to-treat patient population. If ixekizumab is approved for the treatment of ankylosing spondylitis, it would give physicians another option for their patients,” he tells Reuters Health by email.
Axial spondyloarthritis is commonly treated with tumor necrosis factor (TNF) inhibitors, but as many as 40% of patients do not achieve adequate disease control or symptom relief with TNF inhibitors. Ixekizumab is a monoclonal antibody that selectively targets IL-17A, which has been implicated in the immunopathology of axial spondyloarthritis.
Dr. Deodhar and colleagues investigated the efficacy and safety of ixekizumab (vs. placebo) in 316 patients with active radiographic axial spondyloarthritis with previous inadequate response or intolerance to one or two TNF inhibitors.
The proportion of patients who achieved the primary endpoint of 40% improvement in Assessment of SpondyloArthritis International Society (ASAS40) at Week 16 was significantly higher among patients treated with 80 mg ixekizumab every two weeks (30.6%) or every four weeks (25.4%) than among patients treated with placebo (12.5%), the researchers report in Arthritis & Rheumatology, online Oct. 20.1
The findings were also presented at the 2018 ACR/ARHP Annual Meeting Oct. 19–24 in Chicago.
“If I’m a patient, I want greater improvement in my symptoms, and the ASAS40 measure used in this study was very stringent,” Dr. Deodhar says.
More patients in the ixekizumab groups also achieved 20% improvements in ASAS (ASAS20) at 16 weeks (46.9% and 48.2% vs. 29.8%).
Compared with placebo patients, ixekizumab patients had significant improvements in measures of disease activity, function and quality of life.
Spinal MRI and systemic inflammation improved significantly in patients treated with ixekizumab.
More ixekizumab than placebo patients reported treatment emergent adverse events, most of which were mild or moderate in severity. Serious adverse events occurred with similar frequency across treatment arms.
“The current results support ixekizumab as a treatment option in patients with radiographic axial spondyloarthritis and prior inadequate response or intolerance to TNF inhibitors,” the researchers conclude.
Eli Lilly and Company funded the study, employed several authors and financial ties to several more, including Dr. Deodhar.
Reference
- Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: 16 week results of a phase 3 randomized, double-blind, placebo controlled trial in patients with prior inadequate response or intolerance to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2018 Oct 20. doi: 10.1002/art.40753. [Epub ahead of print]