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Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study

Authors :
Namieta M. Janssen
Daniel E. Furst
Roy Fleischmann
John D. Carter
Wei Zhu
Bhaskar Dasgupta
Judy Bryson
Patrick Durez
Kosmas Kretsos
Mark C. Genovese
Costantino Pitzalis
Benjamin Duncan
UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales
UCL - (SLuc) Service de rhumatologie
Source :
Annals of the Rheumatic Diseases, Annals of the Rheumatic Diseases, Vol. 73, no. 9, p. 1607-1615 (2014)
Publication Year :
2014

Abstract

OBJECTIVES: The aim of this 12-week Phase IIb study was to assess the efficacy and safety of olokizumab (OKZ), a humanised anti-IL6 monoclonal antibody, in patients with rheumatoid arthritis (RA) with moderate-to-severe disease activity who had previously failed tumour necrosis factor (TNF) inhibitor therapy. The dose-exposure-response relationship for OKZ was also investigated. METHODS: Patients were randomised to one of nine treatment arms receiving placebo (PBO) or OKZ (60, 120 or 240 mg) every 4 weeks (Q4W) or every 2 weeks (Q2W), or 8 mg/kg tocilizumab (TCZ) Q4W. The primary endpoint was change from baseline in DAS28(C-reactive protein, CRP) at Week 12. Secondary efficacy endpoints were American College of Rheumatology 20 (ACR20), ACR50 and ACR70 response rates at Week 12. Exploratory analyses included comparisons of OKZ efficacy with TCZ. RESULTS: Across 221 randomised patients, OKZ treatment produced significantly greater reductions in DAS28(CRP) from baseline levels at Week 12, compared to PBO (p

Details

ISSN :
14682060
Volume :
73
Issue :
9
Database :
OpenAIRE
Journal :
Annals of the rheumatic diseases
Accession number :
edsair.doi.dedup.....72db8da0988305883926e5f7369d5ec6