Clinical efficacy, radiographic, and safety results of golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior therapy with disease-modifying antirheumatic drugs: Final results of the GO-MONO trial through week 120

the GO-MONO study group

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Abstract

Objective: Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs. Methods: Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted. Assessments included ACR20/50/70 responses and good/moderate DAS28-ESR responses. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Safety and efficacy were assessed through week 120. Results: ACR20 response rates at week 52 in Group 1, Group 2, and Group 3 were 70.6%, 71.4%, and 81.9%, respectively, and maintained through week 104 (87.2%, 85.1%, 88.9%, respectively) and week 120 (86.1%, 87.0%, 89.5%, respectively). Similar trends were observed for ACR50, ACR 70, and DAS28-ESR. Median change in total vdH-S at weeks 52, 104, and 120 ranged from 0.0 to 1.5 across treatment groups. Through week 120, 93.8%/97.1% had an AE with golimumab 50 mg/100 mg, respectively, and 19.7%/11.8% had an SAE. Infections were the most common AE. Conclusion: Clinical response to golimumab 50 mg and 100 mg was maintained over 2 years in Japanese patients with active RA despite prior DMARDs.

Original languageEnglish
Pages (from-to)770-779
Number of pages10
JournalModern Rheumatology
Volume28
Issue number5
DOIs
Publication statusPublished - 2018 Sep 3

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Antirheumatic Agents
Rheumatoid Arthritis
Safety
Therapeutics
golimumab
Placebos
Infection

Keywords

  • Anti-tumor necrosis factor
  • golimumab
  • Japanese
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology

Cite this

@article{50839846675148129c61ed7a00e5666d,
title = "Clinical efficacy, radiographic, and safety results of golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior therapy with disease-modifying antirheumatic drugs: Final results of the GO-MONO trial through week 120",
abstract = "Objective: Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs. Methods: Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted. Assessments included ACR20/50/70 responses and good/moderate DAS28-ESR responses. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Safety and efficacy were assessed through week 120. Results: ACR20 response rates at week 52 in Group 1, Group 2, and Group 3 were 70.6{\%}, 71.4{\%}, and 81.9{\%}, respectively, and maintained through week 104 (87.2{\%}, 85.1{\%}, 88.9{\%}, respectively) and week 120 (86.1{\%}, 87.0{\%}, 89.5{\%}, respectively). Similar trends were observed for ACR50, ACR 70, and DAS28-ESR. Median change in total vdH-S at weeks 52, 104, and 120 ranged from 0.0 to 1.5 across treatment groups. Through week 120, 93.8{\%}/97.1{\%} had an AE with golimumab 50 mg/100 mg, respectively, and 19.7{\%}/11.8{\%} had an SAE. Infections were the most common AE. Conclusion: Clinical response to golimumab 50 mg and 100 mg was maintained over 2 years in Japanese patients with active RA despite prior DMARDs.",
keywords = "Anti-tumor necrosis factor, golimumab, Japanese, rheumatoid arthritis",
author = "{the GO-MONO study group} and Tsutomu Takeuchi and Masayoshi Harigai and Yoshiya Tanaka and Hisashi Yamanaka and Naoki Ishiguro and Kazuhiko Yamamoto and Nobuyuki Miyasaka and Takao Koike and Yoshifumi Ukyo and Yutaka Ishii and Toru Yoshinari and Daniel Baker",
year = "2018",
month = "9",
day = "3",
doi = "10.1080/14397595.2017.1404731",
language = "English",
volume = "28",
pages = "770--779",
journal = "Modern Rheumatology",
issn = "1439-7595",
publisher = "Springer Japan",
number = "5",

}

TY - JOUR

T1 - Clinical efficacy, radiographic, and safety results of golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior therapy with disease-modifying antirheumatic drugs

T2 - Final results of the GO-MONO trial through week 120

AU - the GO-MONO study group

AU - Takeuchi, Tsutomu

AU - Harigai, Masayoshi

AU - Tanaka, Yoshiya

AU - Yamanaka, Hisashi

AU - Ishiguro, Naoki

AU - Yamamoto, Kazuhiko

AU - Miyasaka, Nobuyuki

AU - Koike, Takao

AU - Ukyo, Yoshifumi

AU - Ishii, Yutaka

AU - Yoshinari, Toru

AU - Baker, Daniel

PY - 2018/9/3

Y1 - 2018/9/3

N2 - Objective: Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs. Methods: Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted. Assessments included ACR20/50/70 responses and good/moderate DAS28-ESR responses. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Safety and efficacy were assessed through week 120. Results: ACR20 response rates at week 52 in Group 1, Group 2, and Group 3 were 70.6%, 71.4%, and 81.9%, respectively, and maintained through week 104 (87.2%, 85.1%, 88.9%, respectively) and week 120 (86.1%, 87.0%, 89.5%, respectively). Similar trends were observed for ACR50, ACR 70, and DAS28-ESR. Median change in total vdH-S at weeks 52, 104, and 120 ranged from 0.0 to 1.5 across treatment groups. Through week 120, 93.8%/97.1% had an AE with golimumab 50 mg/100 mg, respectively, and 19.7%/11.8% had an SAE. Infections were the most common AE. Conclusion: Clinical response to golimumab 50 mg and 100 mg was maintained over 2 years in Japanese patients with active RA despite prior DMARDs.

AB - Objective: Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs. Methods: Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted. Assessments included ACR20/50/70 responses and good/moderate DAS28-ESR responses. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score. Safety and efficacy were assessed through week 120. Results: ACR20 response rates at week 52 in Group 1, Group 2, and Group 3 were 70.6%, 71.4%, and 81.9%, respectively, and maintained through week 104 (87.2%, 85.1%, 88.9%, respectively) and week 120 (86.1%, 87.0%, 89.5%, respectively). Similar trends were observed for ACR50, ACR 70, and DAS28-ESR. Median change in total vdH-S at weeks 52, 104, and 120 ranged from 0.0 to 1.5 across treatment groups. Through week 120, 93.8%/97.1% had an AE with golimumab 50 mg/100 mg, respectively, and 19.7%/11.8% had an SAE. Infections were the most common AE. Conclusion: Clinical response to golimumab 50 mg and 100 mg was maintained over 2 years in Japanese patients with active RA despite prior DMARDs.

KW - Anti-tumor necrosis factor

KW - golimumab

KW - Japanese

KW - rheumatoid arthritis

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U2 - 10.1080/14397595.2017.1404731

DO - 10.1080/14397595.2017.1404731

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C2 - 29219638

AN - SCOPUS:85053304804

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JO - Modern Rheumatology

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SN - 1439-7595

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