Spondyloarthritis & psoriatic arthritis
Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program
An erratum to this article was published (J Rheumatol, May 2023 ↗)
Authors' conclusion
The 3-year safety profile of IXE in the COAST program is consistent with the previously established long-term safety profile. IXE Q4W provided sustained improvement of disease activity in patients who received treatment through 3 years.
Study context
- Population
- Patients with axSpA from the COAST program (COAST-V, COAST-W, COAST-X) continuing into COAST-Yreceived ≥ 1 dose of ixekizumab (IXE)
- Participants
- 932 patients
- Comparison
- Ixekizumab 80 mg Q4W or Q2W, long-term
Methodological detailsopen-label extension, pooled analysis of COAST-V, COAST-W, COAST-X and COAST-Y, as-observed analysis
- Open-label extension
- Pooled analysis of COAST-V, COAST-W, COAST-X and COAST-Y
- As-observed analysis
Primary result
As reported in the abstract
Efficacy in patients receiving IXE Q4W · 3 years
- All patient groups receiving IXE Q4W saw sustained improvements in ASDAS, clinically important improvement, and other efficacy end points
- Data summarized as observed
Safety
Treatment-emergent adverse events (TEAEs) · 3 years
- Incidence rate (IR) per 100 patient-years (PYs)
- 38.0
- Majority mild or moderate in severity
Infections (most frequent TEAE) · 3 years
- IR per 100 PYs
- 25.7
Injection site reactions · 3 years
- IR per 100 PYs
- 7.4
TEAEs leading to discontinuation · 3 years
- Proportion of TEAEs
- 7.1%
- IR per 100 PYs
- 3.1
Original publication
Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. Published 15 February 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →