title: Clinical efficacy, radiographic progression, and safety through 156 weeks of therapy with subcutaneous golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis despite prior methotrexate therapy: final results of the randomized GO-FORTH trial.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA).
  
  
  METHODS
  Japanese patients with active RA despite MTX were randomized to placebo + MTX (Group 1, n = 88), golimumab 50 mg + MTX (Group 2, n = 86), or golimumab 100 mg + MTX (Group 3, n = 87). Patients with <20% improvement in swollen/tender joint counts entered early escape at week 16. At week 24, all remaining placebo patients crossed over to golimumab 50 mg. Efficacy assessments included ACR20, DAS28-ESR, and HAQ-DI. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score.
  
  
  RESULTS
  ACR20 response rates in Group 1, Group 2, and Group 3 were 67.9, 86.1, and 82.4%, respectively, at week 52 and were maintained through week 104 (87.1, 94.0, and 88.7%) and week 156 (97.1, 94.1, and 89.5%). Proportions of patients with good/moderate DAS28-ESR response or clinically meaningful improvement in HAQ-DI were also maintained through week 156. The majority of patients did not experience radiographic progression through week 156. Among 257 golimumab-treated patients, 251 (97.7%) had ≥1 AE; 54 (21.0%) had ≥1 serious AE through week 156. Infections were the most common type of AE.
  
  
  CONCLUSIONS
  Response to golimumab + MTX was maintained over 3 years in Japanese patients with active RA despite MTX. Safety results were consistent with the known safety profile of golimumab.
authors.affiliation: a The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health, Japan , Kitakyushu , Japan .
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: b Department of Pharmacovigilance , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan .
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.affiliation: c Division of Rheumatology, Department of Internal Medicine , School of Medicine, Keio University , Tokyo , Japan .
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: d Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan .
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.affiliation: e Department of Orthopedic Surgery , Graduate School & Faculty of Medicine, Nagoya University , Nagoya , Japan .
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.affiliation: f Department of Allergy and Rheumatology , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan .
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yamamoto
authors.affiliation: g Department of Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan .
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Miyasaka
authors.affiliation: h NTT Sapporo Medical Center and Department of Medicine II , Hokkaido University Graduate School of Medicine , Sapporo , Japan .
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
authors.affiliation: i Janssen Research & Development, LLC, Spring House , PA , USA .
authors.forename: Daniel
authors.initials: D
authors.lastname: Baker
authors.affiliation: j Janssen Pharmaceutical K.K. , Tokyo , Japan , and.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ishii
authors.affiliation: k Development Planning and Coordination Department , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Yoshinari
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D018592:Cross-Over Studies; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D033023:Foot Joints / Q000000981:diagnostic imaging; D050823:Hand Joints / Q000000981:diagnostic imaging; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use*; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate
keywords: Anti-tumor necrosis factor; Asian; Golimumab; Rheumatoid arthritis