Artículos de revistas
A randomised phase IIb study of mavrilimumab, a novel GM-CSF receptor alpha monoclonal antibody, in the treatment of rheumatoid arthritis
Fecha
2017Registro en:
Annals of the Rheumatic Diseases, Volumen 76, Issue 6, 2018, Pages 1020-1030
14682060
00034967
10.1136/annrheumdis-2016-210624
Autor
Burmester, Gerd R.
McInnes, Iain B.
Kremer, Joel
Miranda, Pedro
Korkosz, Mariusz
Vencovsky, Jiri
Rubbert-Roth, Andrea
Mysler, Eduardo
Sleeman, Matthew A.
Godwood, Alex
Sinibaldi, Dominic
Guo, Xiang
White, Wendy I.
Wang, Bing
Wu, Chi Yuan
Ryan, Patricia C.
Institución
Resumen
Objectives: Despite the therapeutic value of current rheumatoid arthritis (RA) treatments, agents with alternative modes of action are required. Mavrilimumab, a fully human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, was evaluated in patients with moderate-to-severe RA. Methods: In a phase IIb study (NCT01706926), patients with inadequate response to ≥1 synthetic disease-modifying antirheumatic drug(s), Disease Activity Score 28 (DAS28)-C reactive protein (CRP)/erythrocyte sedimentation rate ≥3.2, ≥4 swollen joints despite methotrexate (MTX) were randomised 1:1:1:1 to subcutaneous mavrilimumab (150, 100, 30 mg), or placebo every other week (eow), plus MTX for 24 weeks. Coprimary outcomes were DAS28-CRP change from baseline to week 12 and American College of Rheumatology (ACR) 20 response rate (week 24). Results: 326 patients were randomised (150 mg, n=79; 100 mg, n=85; 30 mg, n=81; placebo, n=81); 305 completed the study (September 201