Journal
MODERN RHEUMATOLOGY
Volume 26, Issue 1, Pages 15-23Publisher
TAYLOR & FRANCIS LTD
DOI: 10.3109/14397595.2015.1074648
Keywords
Anti-IL6; Anti-TNF therapy failures; DMARDs (biologic); Olokizumab; Rheumatoid arthritis
Categories
Funding
- UCB Pharma
- AbbVie GK.
- Astellas Pharma
- Astra Zeneca K.K.
- Bristol-Myers K.K.
- Chugai Pharmaceutical Co, Ltd.
- Daiichi Sankyo Co., Ltd.
- Eli Lilly Japan K.K.
- Eisai Co., Ltd.
- Janssen Pharmaceutical K.K.
- Mitsubishi Tanabe Pharma Co.
- Novartis Pharma K.K.
- Pfizer Japan Inc.
- Santen Pharmaceutical Co., Ltd.
- Takeda Pharmaceutical Co., Ltd.
- Teijin Pharma Ltd.
- AbbVie GK
- Asahikasei Pharma Corp.
- Taisho Toyama Pharmaceutical Co., Ltd.
- SymBio Pharmaceuticals Ltd
- Abbvie
- Astellas
- Bristol-Myers Squibb
- Chugai
- Daiichi-Sankyo
- Eisai
- GlaxoSmithKline
- Janssen
- Mitsubishi-Tanabe
- Novartis
- Pfizer
- Takeda
- Santen
- BMS
- R-Pharm
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Objectives: This phase II, dose-ranging, double-blind, placebo-controlled, randomized study (NCT01463059) evaluated efficacy and safety of olokizumab (OKZ), a humanized anti-interleukin 6 monoclonal antibody, in Asian patients with moderately-to-severely active rheumatoid arthritis (RA) who had previously failed anti-TNF therapy.Methods: Patients were randomized to one of six treatment arms: placebo or OKZ (60mg/120mg/240mg every four weeks [Q4W]; or 60mg/120mg every two weeks [Q2W]); stratified by country and number of prior anti-TNFs. Primary efficacy variable was Week 12 change from baseline (CFB) in DAS28 CRP for 4-week cumulative dose groups of OKZ and placebo; secondary efficacy variables were Week 12 ACR20/ACR50/ACR70 response rates. Patients continued MTX treatment from baseline, without additional csDMARDs.Results: Of 119 randomized patients, 88.2% completed the study. Greater improvements in DAS28(CRP) mean CFB at Week 12 were observed in all OKZ 4-week cumulative dose groups (60mg/120mg/240mg) versus placebo (p < 0.0001). Week 12 ACR20/ACR50 response rates were higher in all OKZ cumulative dose groups versus PBO (p < 0.05). Incidences of adverse events were similar across OKZ 4-week cumulative dose groups (76.9-84.4%) and placebo (82.8%) with no deaths.Conclusions: OKZ demonstrated improvements in efficacy variables versus placebo in Asian patients with moderately-to-severely active RA who had previously failed anti-TNF therapy. The safety profile was as expected for this class of drug.
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