Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial

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

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5%, 76.8%, 77.6%, and 28.6% at Week 12, and 61.1%, 73.2%, 71.8%, and 24.7% at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL.

Original languageEnglish
Pages (from-to)715-724
Number of pages10
JournalModern Rheumatology
Volume24
Issue number5
DOIs
Publication statusPublished - 2014

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Methotrexate
Rheumatoid Arthritis
Randomized Controlled Trials
Placebos
Safety
Quality of Life
Certolizumab Pegol
Signs and Symptoms
Incidence

Keywords

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

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)

Cite this

Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate : the J-RAPID randomized, placebo-controlled trial. / Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Shoji, Toshiharu; Sakamaki, Yoshiharu; Van Der Heijde, Désirée; Miyasaka, Nobuyuki; Koike, Takao.

In: Modern Rheumatology, Vol. 24, No. 5, 2014, p. 715-724.

Research output: Contribution to journalArticle

Yamamoto, K, Takeuchi, T, Yamanaka, H, Ishiguro, N, Tanaka, Y, Eguchi, K, Watanabe, A, Origasa, H, Shoji, T, Sakamaki, Y, Van Der Heijde, D, Miyasaka, N & Koike, T 2014, 'Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial', Modern Rheumatology, vol. 24, no. 5, pp. 715-724. https://doi.org/10.3109/14397595.2013.864224
Yamamoto, Kazuhiko ; Takeuchi, Tsutomu ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Tanaka, Yoshiya ; Eguchi, Katsumi ; Watanabe, Akira ; Origasa, Hideki ; Shoji, Toshiharu ; Sakamaki, Yoshiharu ; Van Der Heijde, Désirée ; Miyasaka, Nobuyuki ; Koike, Takao. / Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate : the J-RAPID randomized, placebo-controlled trial. In: Modern Rheumatology. 2014 ; Vol. 24, No. 5. pp. 715-724.
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abstract = "Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5{\%}, 76.8{\%}, 77.6{\%}, and 28.6{\%} at Week 12, and 61.1{\%}, 73.2{\%}, 71.8{\%}, and 24.7{\%} at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL.",
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author = "Kazuhiko Yamamoto and Tsutomu Takeuchi and Hisashi Yamanaka and Naoki Ishiguro and Yoshiya Tanaka and Katsumi Eguchi and Akira Watanabe and Hideki Origasa and Toshiharu Shoji and Yoshiharu Sakamaki and {Van Der Heijde}, D{\'e}sir{\'e}e and Nobuyuki Miyasaka and Takao Koike",
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T1 - Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate

T2 - the J-RAPID randomized, placebo-controlled trial

AU - Yamamoto, Kazuhiko

AU - Takeuchi, Tsutomu

AU - Yamanaka, Hisashi

AU - Ishiguro, Naoki

AU - Tanaka, Yoshiya

AU - Eguchi, Katsumi

AU - Watanabe, Akira

AU - Origasa, Hideki

AU - Shoji, Toshiharu

AU - Sakamaki, Yoshiharu

AU - Van Der Heijde, Désirée

AU - Miyasaka, Nobuyuki

AU - Koike, Takao

PY - 2014

Y1 - 2014

N2 - Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5%, 76.8%, 77.6%, and 28.6% at Week 12, and 61.1%, 73.2%, 71.8%, and 24.7% at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL.

AB - Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5%, 76.8%, 77.6%, and 28.6% at Week 12, and 61.1%, 73.2%, 71.8%, and 24.7% at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL.

KW - Certolizumab pegol

KW - Methotrexate

KW - Randomized controlled trial

KW - Rheumatoid arthritis

KW - Tumor necrosis factor-alpha inhibitor

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