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

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

研究成果: Article

19 引用 (Scopus)

抄録

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.

元の言語English
ページ(範囲)15-23
ページ数9
ジャーナルModern Rheumatology
26
発行部数1
DOI
出版物ステータスPublished - 2016 1 2

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Rheumatoid Arthritis
Safety
Placebos
Therapeutics
olokizumab
Interleukin-6
Monoclonal Antibodies
Incidence
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Rheumatology

これを引用

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. / Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Amano, Kanzo; Nagamine, Ryuji; Park, Won; Shiozawa, Kazuko; Tsukano, Michishi; Wei, James Cheng Chung; Shao, Jing; Togo, Osamu; Mashimo, Hideki.

:: Modern Rheumatology, 巻 26, 番号 1, 02.01.2016, p. 15-23.

研究成果: Article

Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Yamanaka, Hisashi ; Amano, Kanzo ; Nagamine, Ryuji ; Park, Won ; Shiozawa, Kazuko ; Tsukano, Michishi ; Wei, James Cheng Chung ; Shao, Jing ; Togo, Osamu ; Mashimo, Hideki. / 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. :: Modern Rheumatology. 2016 ; 巻 26, 番号 1. pp. 15-23.
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title = "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.",
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author = "Tsutomu Takeuchi and Yoshiya Tanaka and Hisashi Yamanaka and Kanzo Amano and Ryuji Nagamine and Won Park and Kazuko Shiozawa and Michishi Tsukano and Wei, {James Cheng Chung} and Jing Shao and Osamu Togo and Hideki Mashimo",
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T1 - Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy

T2 - Results from a randomized phase II trial

AU - Takeuchi, Tsutomu

AU - Tanaka, Yoshiya

AU - Yamanaka, Hisashi

AU - Amano, Kanzo

AU - Nagamine, Ryuji

AU - Park, Won

AU - Shiozawa, Kazuko

AU - Tsukano, Michishi

AU - Wei, James Cheng Chung

AU - Shao, Jing

AU - Togo, Osamu

AU - Mashimo, Hideki

PY - 2016/1/2

Y1 - 2016/1/2

N2 - 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.

AB - 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.

KW - Anti-IL6

KW - Anti-TNF therapy failures

KW - DMARDs (biologic)

KW - Olokizumab

KW - Rheumatoid arthritis

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DO - 10.3109/14397595.2015.1074648

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