Spondyloarthritis & psoriatic arthritis
Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study
An erratum to this article was published (Arthritis Res Ther, 15 Sep 2023 ↗)
Authors' conclusion
Results from COSMOS participants with active, TNFi-IR PsA suggest guselkumab reduces levels of effector cytokines associated with the IL-23/IL-17 pathway, including those associated with baseline arthritis and skin disease activity.
Study context
- Population
- Adults with active psoriatic arthritis (PsA) (≥ 3 swollen joints, ≥ 3 tender joints) and inadequate response (IR) to one or two tumor necrosis factor inhibitors (TNFi)
- Comparison
- Guselkumab Q8W vs placebo➔guselkumab; biomarkers compared with matched healthy controls
- Primary endpoint
- Serum cytokine and acute phase protein levels (IFNɣ, IL-10, TNFα, IL-17A, IL-17F, IL-22, CRP, IL-6, SAA) vs matched healthy controls and guselkumab pharmacodynamics
- Follow-up
- Week 24
Methodological detailsphase 3b, randomized 2:1, placebo-controlled, early escape at Week 16, biomarker analysis vs matched healthy controls
- Phase 3b
- Randomized 2:1
- Placebo-controlled
- Early escape at Week 16
- Biomarker analysis vs matched healthy controls
Primary result
As reported in the abstract
Serum biomarkers
- Baseline IL-6, IL-10, IL-17A, IL-17F, IL-22, TNFα and IFNɣ significantly higher in TNFi-IR participants than matched healthy controls
- At Week 24, significant decreases from baseline in C-reactive protein (CRP), serum amyloid A (SAA), IL-17A, IL-17F and IL-22 with guselkumab, not with placebo
- IL-17F and IL-22 at Week 24 with guselkumab did not significantly differ from matched healthy controls
Further findings
Association of baseline biomarkers with baseline disease activity
- Baseline IL-6, CRP and SAA associated with baseline DAS28-CRP
- IL-17A and IL-17F associated with baseline PASI and psoriasis BSA
- Baseline swollen or tender joint counts not associated with baseline biomarker levels
Baseline biomarkers by ACR20 response with guselkumab · Week 24
- ACR20 responders had higher baseline IL-22 and IFNɣ vs nonresponders
Original publication
Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. Arthritis Res Ther. Published 16 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →