Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial.

Abstract

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 (60 mg/120 mg/240 mg every four weeks [Q4W]; or 60 mg/120 mg 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 (60 mg/120 mg/240 mg) 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.

• Authors: Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Kanzo Amano, Ryuji Nagamine, Won Park, Kazuko Shiozawa, Michishi Tsukano, James Cheng-Chung Wei, Jing Shao, Osamu Togo, Hideki Mashimo
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 26 Issue 1 Pg. 15-23 ( 2016) ISSN: 1439-7609 [Electronic] England
• PMID: 26358841 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• TNF protein, human
• Tumor Necrosis Factor-alpha
• olokizumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Tumor Necrosis Factor-alpha