title: Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study.
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.
  
  
  CONCLUSIONS
  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.
authors: The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Japan. tanaka@med.uoeh-u.ac.jp
authors: Yoshiya
authors: Y
authors: Tanaka
authors: Masayoshi
authors: M
authors: Harigai
authors: Tsutomu
authors: T
authors: Takeuchi
authors: Hisashi
authors: H
authors: Yamanaka
authors: Naoki
authors: N
authors: Ishiguro
authors: Kazuhiko
authors: K
authors: Yamamoto
authors: Nobuyuki
authors: N
authors: Miyasaka
authors: Takao
authors: T
authors: Koike
authors: Minoru
authors: M
authors: Kanazawa
authors: Takuya
authors: T
authors: Oba
authors: Toru
authors: T
authors: Yoshinari
authors: Daniel
authors: D
authors: Baker
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000208:ethnology; D044466:Asian People; D018450:Disease Progression; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008875:Middle Aged; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate