Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis

The HIKARI randomized, placebo-controlled trial

Kazuhiko Yamamoto, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Yoshiya Tanaka, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Koichi Iwai, Yoshiharu Sakamaki, Désirée Van Der Heijde, Nobuyuki Miyasaka, Takao Koike

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Objective. This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered. Methods. A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks. Results. ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) and Week 24 (63.8% vs. 11.4%). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2% vs. 20.0%; without [monotherapy], 59.3% vs. 8.2%) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2% (CZP) and 2.6% (placebo); one CZP patient died of dissecting aortic aneurysm. Conclusion. CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression.

Original languageEnglish
Pages (from-to)552-560
Number of pages9
JournalModern Rheumatology
Volume24
Issue number4
DOIs
Publication statusPublished - 2014

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Methotrexate
Rheumatoid Arthritis
Randomized Controlled Trials
Placebos
Safety
Antirheumatic Agents
Certolizumab Pegol
Dissecting Aneurysm
Aortic Aneurysm
Double-Blind Method
Signs and Symptoms
Incidence
Therapeutics

Keywords

  • Certolizumab pegol
  • Monotherapy
  • Randomized controlled trial
  • Rheumatoid arthritis
  • Tumor necrosis factor-alpha inhibitor

ASJC Scopus subject areas

  • Rheumatology

Cite this

Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis : The HIKARI randomized, placebo-controlled trial. / Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Iwai, Koichi; Sakamaki, Yoshiharu; Van Der Heijde, Désirée; Miyasaka, Nobuyuki; Koike, Takao.

In: Modern Rheumatology, Vol. 24, No. 4, 2014, p. 552-560.

Research output: Contribution to journalArticle

Yamamoto, K, Takeuchi, T, Yamanaka, H, Ishiguro, N, Tanaka, Y, Eguchi, K, Watanabe, A, Origasa, H, Iwai, K, Sakamaki, Y, Van Der Heijde, D, Miyasaka, N & Koike, T 2014, 'Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: The HIKARI randomized, placebo-controlled trial', Modern Rheumatology, vol. 24, no. 4, pp. 552-560. https://doi.org/10.3109/14397595.2013.843764
Yamamoto, Kazuhiko ; Takeuchi, Tsutomu ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Tanaka, Yoshiya ; Eguchi, Katsumi ; Watanabe, Akira ; Origasa, Hideki ; Iwai, Koichi ; Sakamaki, Yoshiharu ; Van Der Heijde, Désirée ; Miyasaka, Nobuyuki ; Koike, Takao. / Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis : The HIKARI randomized, placebo-controlled trial. In: Modern Rheumatology. 2014 ; Vol. 24, No. 4. pp. 552-560.
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abstract = "Objective. This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered. Methods. A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks. Results. ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2{\%} vs. 14.9{\%}) and Week 24 (63.8{\%} vs. 11.4{\%}). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2{\%} vs. 20.0{\%}; without [monotherapy], 59.3{\%} vs. 8.2{\%}) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2{\%} (CZP) and 2.6{\%} (placebo); one CZP patient died of dissecting aortic aneurysm. Conclusion. CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression.",
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AU - Takeuchi, Tsutomu

AU - Yamanaka, Hisashi

AU - Ishiguro, Naoki

AU - Tanaka, Yoshiya

AU - Eguchi, Katsumi

AU - Watanabe, Akira

AU - Origasa, Hideki

AU - Iwai, Koichi

AU - Sakamaki, Yoshiharu

AU - Van Der Heijde, Désirée

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AB - Objective. This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered. Methods. A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks. Results. ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) and Week 24 (63.8% vs. 11.4%). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2% vs. 20.0%; without [monotherapy], 59.3% vs. 8.2%) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2% (CZP) and 2.6% (placebo); one CZP patient died of dissecting aortic aneurysm. Conclusion. CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression.

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