Spondyloarthritis & psoriatic arthritis
Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials
Authors' conclusion
In this integrated safety analysis, consisting of over 22,000 PY of exposure, the long-term safety profile of IXE was found to be consistent with previous, earlier reports, with no new safety signals identified.
Study context
- Population
- Adults with psoriasis, psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) (including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)) who received any dose of ixekizumab in 25 randomized clinical trials (RCTs), through March 202222,371.1 patient-years (PY) Ixekizumab (IXE) exposure
- Participants
- 6,892 / 1,401 / 932
- Comparison
- PsO vs PsA vs axSpA
- PsOn = 6,892
- PsAn = 1,401
- axSpAn = 932
- Primary endpoint
- Exposure-adjusted incidence rates (IRs) per 100 PY of TEAEs, serious adverse events (SAEs) and selected adverse events (AEs) of interest
Methodological detailspooled studies (17 PsO, 4 PsA, 4 axSpA), exposure-adjusted incidence rates per 100 PY
- Pooled studies (17 PsO, 4 PsA, 4 axSpA)
- Exposure-adjusted incidence rates per 100 PY
Primary result
As reported in the abstract
| Group | Value | IR |
|---|---|---|
| PsO | 969 events | 5.4 |
| PsA | 134 events | 6.0 |
| axSpA | 101 events | 4.8 |
Value
IR
Further findings
| Outcome | PsO | PsA | axSpA |
|---|---|---|---|
| Deaths | |||
| IR | 0.2 | 0.3 | 0.1 |
- Deaths — Total deaths
- 45
Safety
Nasopharyngitis, most common TEAE (IR per 100 PY)
Discontinuation of IXE due to AE (IR per 100 PY)
Injection site reactions (IR per 100 PY)
Candida (IR per 100 PY)
Adjudicated inflammatory bowel disease (IR per 100 PY)
| Outcome | PsO | PsA | axSpA |
|---|---|---|---|
| TEAEs over time (IR per 100 PY, first to last interval) | 88.9 to 63.2 per 100 PY | 87 to 67.3 per 100 PY | 82.1 to 55.4 per 100 PY |
| Interval | year 0-1 to 4-5 | year 0-1 to 2-3 | year 0-1 to > = 2 |
- Adjudicated inflammatory bowel disease (IR per 100 PY): ≤ 0.8 across indications
Treatment-emergent adverse events (TEAEs) over time (IR per 100 PY, first to last interval)
- TEAEs did not increase during IXE exposure
Depression, MACE (cerebro-cardiovascular) and malignancies (IR per 100 PY)
- ≤ 1.6 across all indications
Original publication
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