Spondyloarthritis & psoriatic arthritis
Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial
An erratum to this article was published (Lancet Rheumatol, Aug 2024 ↗)
Primary result · ASAS20 clinical responseResult — go to the resultEstimated between-group difference 6.8%Authors' conclusion
Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated.
Study context
- Population
- Adults 18–75 years with moderate-to-severe active axSpA meeting ASAS and ASAS-defined MRI criteria, active disease by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); prior TNFi inadequate response or intolerance allowed; nine UK hospitalsrandomly assigned
- Participants
- 42 adults
- Comparison
- Subcutaneous namilumab 150 mg vs placebo at weeks 0, 2, 6 and 10
- Namilumabn = 36
- Placebon = 6reference
- Primary endpoint
- Proportion with ASAS20 clinical response in the full analysis set (all randomly assigned participants)
- Follow-up
- Week 12
Methodological detailsproof-of-concept, double-blind, placebo-controlled, phase 2, Bayesian, multicentre (nine hospitals), 6:1 randomisation
- Proof-of-concept
- Double-blind
- Placebo-controlled
- Phase 2
- Bayesian
- Multicentre (nine hospitals)
- 6:1 randomisation
Primary result
ASAS20 clinical response
Estimated between-group difference
6.8%
Events by treatment group
Namilumab
14
events
Placebo
3
events
As reported in the abstract
Safety
Events
| Outcome | Namilumab | Placebo |
|---|---|---|
| Any treatment-emergent adverse events | 31 | 5 |
Any treatment-emergent adverse events
- Rates similar in the two groups
Original publication
Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. Published 25 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →