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Extended report
Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study
  1. Yoshiya Tanaka1,
  2. Masayoshi Harigai2,
  3. Tsutomu Takeuchi3,
  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-FORTH Study Group
  1. 1The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Japan
  2. 2Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan
  3. 3Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Shinjuko-ku, Tokyo, Japan
  4. 4Institute of Rheumatology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan
  5. 5Department of Orthopaedic Surgery, Nagoya University, Graduate School & Faculty of Medicine, Nagoya, Japan
  6. 6Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  7. 7Department of Medicine & 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 KK, Chiyoda-ku, Tokyo, Japan
  11. 11Mitsubishi Tanabe Pharmaceutical Corporation, Chuo-ku, Tokyo, Japan
  12. 12Centocor Research & Development (a division of Johnson & Johnson Pharmaceutical Research & Development, LLC), Malvern, Pennsylvania, USA
  1. Correspondence to Yoshiya Tanaka, The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka 807-8555, Japan; tanaka{at}med.uoeh-u.ac.jp

Abstract

Objective To assess the efficacy and safety of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA).

Methods 269 Japanese patients with active RA despite treatment with MTX were randomised (1:1:1) to placebo + MTX (Group 1), golimumab 50 mg + MTX (Group 2) or golimumab 100 mg + MTX (Group 3). Subcutaneous golimumab/placebo was injected every 4 weeks; stable doses of oral MTX (6–8 mg/week) were continued. Patients were allowed to enter early escape (Group 1 added golimumab 50 mg, Group 2 increased golimumab to 100 mg, Group 3 continued golimumab 100 mg) based on swollen/tender joint counts at week 14. The primary study endpoint was achievement of at least 20% improvement in the American College of Rheumatology (ACR20) response criteria at week 14. To control for multiplicity of testing, treatment group comparisons were first made between combined Groups 2 and 3 versus Group 1, followed by comparisons of Group 2 and Group 3 versus Group 1.

Results The proportion of patients with an ACR20 response at week 14 was significantly higher in combined Groups 2 and 3 (73.4%, 127/173) and in each of Group 2 (72.1%, 62/86) and Group 3 (74.7%, 65/87) compared with Group 1 (27.3%, 24/88; p<0.0001 for all comparisons). Golimumab + MTX also elicited a significantly better response than placebo + MTX in other efficacy parameters, including disease activity score (DAS28) response/remission and radiographic assessments. During the 16-week fixed treatment regimen study period, 72.7%, 75.6% and 78.2% of patients had adverse events and 1.1%, 1.2% and 2.3% had serious adverse events in Groups 1, 2 and 3, respectively.

Conclusion In Japanese patients with active RA despite MTX therapy, golimumab + MTX was significantly more effective than MTX monotherapy in reducing RA signs/symptoms and limiting radiographic progression with no unexpected safety concerns.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

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Footnotes

  • Funding This study was funded by Centocor Research & Development Inc, Janssen Pharmaceuticals KK and Mitsubishi Tanabe Pharmaceutical Corporation.

  • Competing interests DB is an employee of Centocor, a fully-owned subsidiary of Johnson & Johnson and owns stock in Johnson & Johnson. HY has received research grants from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Eizai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Otsuka Pharmaceutical, Roche, Takeda Pharmaceutical and Wyeth. KY has received research grants from Astellas Pharmaceutical, Chugai Pharmaceutical, Eizai Pharmaceutical, Immunofuture Inc, Mitsubishi Tanabe Pharmaceutical, Santen Pharmaceutical and Wyeth. MH has received research grants from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Eizai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Takeda Pharmaceutical and Wyeth, as well as consulting fees from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Janssen Pharmaceutical and Mitsubishi Tanabe Pharmaceutical. MK has received research grants from Astellas Pharmaceutical, Astra Zeneca, Banyu Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eizai Pharmaceutical, GlaxoSmith Kline, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical and Nippon Boehringer Ingelheim. NI has received research grants from Astellas Pharmaceutical, Chugai Pharmaceutical, Eizai Pharmaceutical and Mitsubishi Tanabe Pharmaceutical. NM has received research grants from Abbott, Astellas Pharmaceutical, Banyu Pharmaceutical, Chugai Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eizai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Takeda Pharmaceutical and Teijin Pharmaceutical. TK has received research grants from Abbott, Bristol Myers Squibb, Chugai Pharmaceutical, Eizai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Takeda Pharmaceutical and Wyeth. TO is an employee of Janssen Pharmaceutical KK, a fully-owned subsidiary of Johnson & Johnson. TT has received research grants from Abbott, Astra Zeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Eizai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Novartis, Takeda Pharmaceutical and Wyeth. TY is an employee of Mitsubishi Tanabe Pharmaceutical. YT has received research grants from Abbott, Astellas Pharmaceutical, Banyu Pharmaceutical, Chugai Pharmaceutical, Eizai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Pfizer and Takeda Pharmaceutical.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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