title: Efficacy and safety results from a Phase 3, randomized, placebo-controlled trial of subcutaneous golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy.
abstract: OBJECTIVE
  The efficacy and safety of golimumab + methotrexate (MTX) were evaluated in Chinese patients with active rheumatoid arthritis (RA) despite MTX therapy.
  
  
  METHODS
  Chinese patients (n = 264) were randomly assigned (1 : 1) to receive subcutaneous injections of placebo + MTX with crossover to golimumab 50 mg + MTX at week 24 (Group 1) or to golimumab 50 mg + MTX (Group 2) every 4 weeks. Group 1 patients with inadequate response entered blinded early escape to golimumab 50 mg + MTX at week 16. At least a 20% improvement in the American College of Rheumatology (ACR20) criteria at week 14 was the primary endpoint. Other assessments included the 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI) through week 52. Adverse events (AEs) were monitored through week 56.
  
  
  RESULTS
  ACR20 response at week 14 was significantly higher in Group 2 (40.9% [54/132]) compared with Group 1 (15.9% [21/132]; P < 0.001). Greater proportions of patients in Group 2 compared with Group 1 had a DAS28-CRP response at week 14 (65.2% vs. 30.3%, P < 0.001) or ACR20 response at week 24 (42.4% vs. 15.9%, P < 0.001), and Group 2 had a significantly greater change in HAQ-DI at week 24 (-0.26 vs. 0.15, P < 0.001). After week 24, the proportion of patients achieving ACR20 in Group 1 approached that in Group 2. Through week 16, 23.5% of Group 1 and 26.7% of Group 2 patients reported AEs. Among golimumab + MTX-treated patients, 50.2% and 4.2% had ≥ 1 AE or serious AE, respectively, through week 56. No unexpected safety signals were observed.
  
  
  CONCLUSIONS
  Among MTX-experienced Chinese patients with active RA, a significantly greater proportion of patients receiving golimumab + MTX had improvements in the signs and symptoms of RA compared with MTX monotherapy. Safety findings were consistent with previous studies of golimumab in patients with RA.
authors.affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China.
authors.forename: Zhanguo
authors.initials: Z
authors.lastname: Li
authors.affiliation: Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Fengchun
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kay
authors.affiliation: Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: Kaiyin
authors.initials: K
authors.lastname: Fei
authors.affiliation: Patient-Reported Outcomes, Janssen Global Services, Malvern, Pennsylvania, USA.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.affiliation: Biologics Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: Yanli
authors.initials: Y
authors.lastname: Zhuang
authors.affiliation: Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Wu
authors.affiliation: Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.|Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D002681:China; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate
keywords: Asian; anti-tumor necrosis factor; biologics; rheumatoid arthritis