Objective
To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (
TNF
i).
Methods
In this phase
III
randomized, double‐blind, placebo‐controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2
TNF
i and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [
ASAS
] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80‐mg subcutaneous ixekizumab every 2 weeks (
IXE
Q2W) or 4 weeks (
IXEQ4W
), with an 80‐mg or 160‐mg starting dose. The primary end point was 40% improvement in disease activity according to the
ASAS
criteria (
ASAS
40) at week 16. Secondary outcomes and safety were also assessed.
Results
A total of 316 patients were randomized to receive placebo (n = 104),
IXEQ2W
(n = 98), or
IXEQ4W
(n = 114). At week 16, significantly higher proportions of
IXEQ2W
patients (n = 30 [30.6%];
P
= 0.003) or
IXEQ4W
patients (n = 29 [25.4%];
P
= 0.017) had achieved an
ASAS
40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging–evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment‐emergent adverse events (
AE
s) with ixekizumab treatment were more frequent than with placebo. Serious
AE
s were similar across treatment arms. One death was reported (
IXEQ2W
group).
Conclusion
Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2
TNF
i yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.
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