Session Type: Poster Session (Monday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Week 16 results from COAST-W (NCT02696798) showed that ixekizumab (IXE) was superior to placebo (PBO) in improving the signs and symptoms of active radiographic axial spondyloarthritis (r-axSpA) in patients with prior inadequate response (IR) or intolerance to tumor necrosis factor inhibitors (TNFi).1 Long-term efficacy and safety of IXE in this population have not been reported. The objective of the study was to assess the efficacy and safety of IXE through 52 weeks of continuous treatment in TNF-IR patients.
Methods: Adults with active r-axSpA (Assessment of SpondyloArthritis international Society [ASAS] criteria) and prior IR/intolerance to 1-2 TNFi were randomized 1:1:1 to PBO or 80 mg IXE every 2 (IXEQ2W) or 4 weeks (IXEQ4W). At Week 16, patients assigned to IXE continued with IXE, and patients assigned to PBO were randomized at 1:1 to IXEQ2W or IXEQ4W through Week 52.
Results: Of 212 patients initially randomized to IXE, 169 (80%) completed Week 52. Both IXE regimens led to sustained improvements in disease activity through 52 weeks (Table). Previously reported1 improvements in function, objective inflammation, quality of life, health status, and overall function were sustained/further improved through 52 weeks. Patients initially randomized to PBO who switched to IXE rapidly achieved similar levels of improvement in signs and symptoms as patients initially randomized to IXE (Table). The frequency of treatment‑emergent adverse events (AEs) through 52 weeks was similar between IXE regimens. In patients who received ≥1 IXE dose (N=305), 16 (5%) reported serious AEs and 23 (7.5%) discontinued due to AEs. Safety through 52 weeks of IXE was consistent with safety through 16 weeks.1
Conclusion: These are the first long-term data on the efficacy and safety of IXE in r-axSpA patients with prior IR/intolerance to TNFi. Both IXE regimens provided similar and sustained improvement in signs and symptoms through 52 weeks, with no unexpected safety signals. Patients who switched to IXE after initial PBO treatment rapidly achieved similar levels of improvement in signs and symptoms of r-axSpA as patients originally randomized to IXE. These findings indicate that in r-axSpA patients with prior IR/intolerance to TNFi, treatment with an alternative mode of action can be successful.
Reference: 1. Deodhar et al. Arthritis Rheumatol, 2018
To cite this abstract in AMA style:Dougados M, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych W, Ermann J, Li X, Gallo G, Carlier H, Gensler L. Ixekizumab: 52-Week Efficacy and Safety in Radiographic Axial Spondyloarthritis Patients with Prior Inadequate Response/Intolerance to Tumor Necrosis Factor Inhibitors [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/ixekizumab-52-week-efficacy-and-safety-in-radiographic-axial-spondyloarthritis-patients-with-prior-inadequate-response-intolerance-to-tumor-necrosis-factor-inhibitors/. Accessed October 28, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/ixekizumab-52-week-efficacy-and-safety-in-radiographic-axial-spondyloarthritis-patients-with-prior-inadequate-response-intolerance-to-tumor-necrosis-factor-inhibitors/