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 2024:S2665-9913(24)00099-7 DOI 10.1016/S2665-9913(24)00099-7 Epub ahead of print
Worth, et al. found that namilumab did not show efficacy compared with placebo in patients with active axSpA, but the treatment was generally well tolerated. An unusually high proportion of ASAS20 responders at Week 12 were observed in the placebo group, which had a small sample size compared to the namilumab arm.
NAMASTE was a proof-of-concept, randomised, double-blind, placebo-controlled, Phase 2, Bayesian trial carried out in nine hospitals in the UK. The objective of the study was to assess the efficacy of namilumab in participants with moderate-to-severe active axSpA, and to determine whether granulocyte-macrophage colony-stimulating factor inhibition should be further investigated in larger scale clinical trials as a novel therapy for this patient population. 42 patients with axSpA were randomised 6:1 to Namilumab 150mg or placebo SC at Weeks 0, 2, 6, and 10. Patient follow-up was carried out up to Week 28.
