van der Heijde D. Evaluation of spinal radiographic progression in patients with radiographic axial spondyloarthritis receiving ixekizumab therapy over 2 years. Presented at EULAR 2021 Congress; June 2-6, 2021 (virtual meeting).van der Heijde reports consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squib, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, as well as employment as director of imaging at Rheumatology bv.
Most patients with active, radiographic axial spondyloarthritis who receive ixekizumab for 2 years show no radiographic disease progression, with low mean progression overall, according to a poster presentation at the EULAR 2021 Congress.
Désirée van der Heijde
“Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A, and it has demonstrated efficacy in clinical trials of patients with radiographic axial spondyloarthritis/ankylosing spondylitis,” Désirée van der Heijde, MD, PhD, of Leiden University Medical Center, in the Netherlands, said during a poster session for the virtual meeting. “The COAST-V trial included patients who were naïve to biologic disease-modifying anti-rheumatic drugs, and the COAST-W trial included patients with TNF-inhibitor experience [and had an intolerance or inadequate response].”
“The patients who completed 1 year of COAST-V or COAST-W were eligible to enroll in the COAST-Y trial,” she added. “This is an ongoing, phase 3 long-term extension study.”
To examine spinal radiographic progression, and its possible predictors, in patients with active, radiographic axial SpA and AS who received ixekizumab (Taltz, Eli Lilly & Co.), van der Heijde and colleagues conducted a post-hoc analysis of 2-year data from the COAST-V, COAST-W and COAST-Y studies. A total of 657 participants entered either COAST-V or COAST-W and received 80 mg of ixekizumab every 2 or 4 weeks for 52 weeks. Among these participants, 527 reconsented to enter COAST-Y, where they continued to receive treatment for an additional 56 weeks.
However, 104 participants in COAST-Y were missing either baseline or year 2 data. Among those with complete data, 230 ultimately received ixekizumab for at least 24 months, and were included in the post-hoc analysis. For this study, van der Heijde and colleagues reported the mean changes in the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS), from baseline, among patients treated with ixekizumab for 2 years. In addition, the researchers presented non-progression in all patients and subgroups based on TNF-inhibitor experience, and identified predictors using multivariate logistic regression models.
According to van der Heijde, 89.6% of all participants who received ixekizumab were deemed non-progressors, or those with a change in mSASSS of less than two from baseline over 2 years. Among those who were biologic-naïve, the proportion of non-progressors was 90.9%, and in those with an inadequate response, or intolerance, to TNF inhibitors, it was 88.3%.
The proportions of participants who achieved an mSASSS change of 0 or less from baseline were 75.7% for all patients who received ixekizumab, 78.2% of those who were biologic-naïve, and 73.3% for those with previous experience with a TNF inhibitor.
Predictors of structural progression at year 2 — defined as an mSASSS change of greater than zero — were age, baseline syndesmophytes, HLA-B27 status and gender. Additionally, in a separate model for 109 patients from COAST-V with MRI measures available at baseline and week 52, inflammation at week 52 in MRI SPARCC spine was a predictor of 2-year structural progression.
“There was a low progression rate over 2 years, which was similar in patients who were biologic-naïve or TNF-inhibitor experienced, and predictors were generally consistent with previous studies,” van der Heijde said.