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
N1 - Funding Information:
NI has received research grants from Astellas Pharmaceutical, Chugai Pharmaceutical, Eizai Pharmaceutical, and Mitsubishi Tanabe Pharma Corporation.
Funding Information:
This trial was funded by Janssen Research and Development, LLC, Janssen Pharmaceuticals K.K., and Mitsubishi Tanabe Pharma Corporation. The authors thank Miyo Ota, PhD, of Janssen Pharmaceutical K.K. for statistical support and Rebecca Clemente, PhD, of Janssen Scientific Affairs, LLC, for writing support.
Publisher Copyright:
© 2017, © 2017 Japan College of Rheumatology. Published by Informa UK Limited, trading as Taylor & Francis Group.
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 - Japanese
KW - golimumab
KW - rheumatoid arthritis
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U2 - 10.1080/14397595.2017.1404731
DO - 10.1080/14397595.2017.1404731
M3 - Article
C2 - 29219638
AN - SCOPUS:85053304804
VL - 28
SP - 770
EP - 779
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 5
ER -