Ixekizumab plus background drugs bested background drugs alone in axial SpA
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ATLANTA — Ixekizumab combined with conventional background medication is superior to both conventional background medication alone and placebo in improving signs, symptoms and inflammation based on MRI among patients with nonradiographic axial spondyloarthritis, according to data presented at ACR/ARP 2019.
“Ixekizumab, a high-affinity interleukin-17A monoclonal antibody, previously showed efficacy in ankylosing spondylitis/radiographic axial spondyloarthritis, and has recently been approved in the United States for the treatment of active AS,” Atul Deodhar, MD, MRCP, of the Oregon Health & Science University, in Portland, told attendees.
To examine the efficacy and safety of ixekizumab (Taltz, Eli Lilly) among patients with active nonradiographic axial SpA and objective signs of inflammation, Deodhar and colleagues conducted the phase 3 COAST-X trial. The 52-week, randomized, double-blind study included 303 adults with established axial SpA, a BASDAI and back-pain scores of 4 or greater, and either an inadequate response to, or an intolerance of, NSAIDs. Following stratification based on country and screening MRI or CRP status, participants were randomly assigned to one of three treatment groups.
Among the patients, 96 were treated with 80 mg of ixekizumab every 4 weeks, while 102 received the same treatment and dosage every 2 weeks and 105 received placebo. Changes to background medication, or escape to open-label ixekizumab every 2 weeks, were determined at the investigators’ discretion after 16 weeks. Primary endpoints included ASAS40 response at weeks 16 and 52. The researchers used a logistic regression model with nonresponder imputation for categorical data. In addition, a mixed effects model of repeated measures was used for continuous variables, as well as an analysis of covariance for sacroiliac joint MRI SPARCC scores.
According to the researchers, 40% of patients receiving ixekizumab every 2 weeks, and 35% of those treated every 4 weeks, achieved ASAS40 at week 16, compared with 19% of those who received placebo (P < .01). At week 52, 31% of those treated every 2 weeks, 30% of those treated every 4 weeks and 13% of those in the placebo group achieved the endpoint (P < .01). In addition, participants in both ixekinzumab groups, compared with those who received placebo, demonstrated significantly greater changes in disease activity, functional status and SIJ SPARCC scores from baseline to weeks 16 and 52.
The frequency of serious adverse events, including those that led to treatment discontinuation, was low and similar across all three groups. There were no new safety findings.
“Ixekizumab was superior to placebo for improving signs and symptoms, including inflammation on MRI, in patients with active nonradiographic axial spondyloarthritis,” Deodhar said. “The primary endpoint and all major secondary endpoints were met for both ixekizumab dose groups at week 16 and week 52. In addition, there were no unexpected safety findings. The results demonstrate for the first time that blocking IL-17A is a potential treatment option for patients with non-radiographic axial spondyloarthritis.” – by Jason Laday
Reference:
Deodhar A. Abstract #2729. Ixekizumab in non-radiographic axial spondyloarthritis: Primary results from a phase 3 trial. Presented at: American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting; Nov. 9-13, 2019; Atlanta.
Disclosure: Deodhar reports professional relationships with AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB Pharma.