Spondyloarthritis & psoriatic arthritis
The effect of ixekizumab treatment on MRI sacroiliac joint structural lesions in patients with radiographic axial spondyloarthritis: post-hoc analysis of a 52-week, randomised, placebo-controlled trial with an active reference arm
Authors' conclusion
A decrease in erosion and increase in backfill were observed at week 16 with further reductions in erosion and increases in backfill occurring at week 52 in patients receiving ixekizumab.
Study context
- Population
- bDMARD-naive adults with active r-axSpA, radiographic sacroiliitis and inadequate response or intolerance to NSAIDs; 84 sites in 12 countries325 with MRI at baseline and week 16
- Participants
- 341 adults
- Comparison
- Ixekizumab 80 mg Q2W or Q4W and adalimumab 40 mg Q2W vs placebo
- Primary endpoint
- Change in MRI sacroiliac joint SPARCC structural score for erosion
- Follow-up
- Week 16
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, active reference arm, ANCOVA in observed cases
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Active reference arm
- ANCOVA in observed cases
Primary result
As reported in the abstract
Change in sacroiliac joint erosion score (SPARCC), LS mean
Ixekizumab Q2W
−0.91
least squares mean · SE 0.19
Ixekizumab Q4W
−0.57
least squares mean · SE 0.19
Placebo
0.10
least squares mean · SE 0.18
Ixekizumab Q2W vs Placebo: P < 0.0001 · Ixekizumab Q4W vs Placebo: P = 0.0086
Further findings
| Outcome | Ixekizumab Q2W | Placebo | P value |
|---|---|---|---|
| Change in sacroiliac joint backfill score · week 16Ixekizumab Q2W vs Placebo | 0.52 (SE 0.12) | 0.04 (SE 0.12) | P = 0.0042 |
- Erosion and backfill, continuous ixekizumab Q2W · week 52
- −1.50 · mean · SD 2.70
- Erosion and backfill, continuous ixekizumab Q2W: 301 (88%) patients with MRI at week 52
Erosion and backfill, continuous ixekizumab Q2W · week 52
- Further changes in erosion and backfill at both ixekizumab doses, greatest with continuous Q2W
- Decrease in erosion also in patients switching from adalimumab to ixekizumab
Erosion decrease by sex, HLA-B27 and baseline bone marrow oedema (subgroups) · week 16
- Differences seen by sex, HLA-B27 status, and baseline bone marrow oedema score
Original publication
The effect of ixekizumab treatment on MRI sacroiliac joint structural lesions in patients with radiographic axial spondyloarthritis: post-hoc analysis of a 52-week, randomised, placebo-controlled trial with an active reference arm. Lancet Rheumatol. Published 18 February 2025. doi:10.
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