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Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks
  1. Tsutomu Takeuchi1,
  2. Masayoshi Harigai2,
  3. Yoshiya Tanaka3,
  4. Hisashi Yamanaka4,
  5. Naoki Ishiguro5,
  6. Kazuhiko Yamamoto6,
  7. Nobuyuki Miyasaka7,
  8. Takao Koike8,
  9. Minoru Kanazawa9,
  10. Takuya Oba10,
  11. Toru Yoshinari11,
  12. Daniel Baker12 the GO-MONO study group
  1. 1Division of Rheumatology, Keio University, Shinjuku-ku, Tokyo, Japan
  2. 2Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan
  3. 3First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan
  4. 4Institute of Rheumatology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan
  5. 5Department of Orthopedic Surgery, Nagoya University, Nagoya, Aichi, Japan
  6. 6Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  7. 7Department of Medicine and Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan
  8. 8Sapporo Medical Center NTT EC, Sapporo, Japan
  9. 9Respiratory Center, Saitama medical University, Moroyama-machi, Iruma-gun, Saitama, Japan
  10. 10Janssen Pharmaceutical K.K., Chiyoda-ku Tokyo, Japan
  11. 11Mitsubishi Tanabe Pharma Corporation, Chuo-ku Tokyo, Japan
  12. 12Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  1. Correspondence to Professor Tsutomu Takeuchi, Division of Rheumatology, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan;tsutake{at}


Objective To evaluate the efficacy and safety of golimumab 50 and 100 mg monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying antirheumatic drugs (DMARDs).

Methods A total of 316 patients were randomised to receive subcutaneous injections every 4 weeks of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3); group 1 crossed over to golimumab 50 mg at week 16. The primary end point was the proportion of patients achieving ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14. ACR50 and ACR70 response rates were also measured. Adverse events (AEs) were monitored throughout the study.

Results Demographics were similar across groups; the mean age was 52 years and 81.8% of patients (252/308) were female. Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5%)) and 3 (60/102 (58.8%)) than in group 1 (20/105 (19.0%); p<0.0001 for both), as were ACR50 and ACR70 response rates. After placebo crossover at week 16, week 24 ACR response rates were similar in groups 1 and 2. Through week 16, 63.8% of patients in group 1, 62.4% in group 2 and 60.8% in group 3 had AEs and 1.9%, 1.0% and 2.0% had serious AEs. After week 16, one malignancy was reported (breast cancer, group 3). Infections were the most common AEs. No deaths or cases of tuberculosis were reported through week 24.

Conclusions Golimumab monotherapy (50 and 100 mg) was effective in reducing the signs and symptoms of RA in Japanese patients with active disease despite DMARD treatment.

  • Rheumatoid Arthritis
  • Anti-TNF
  • Treatment

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