title: Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of golimumab (GOL), a human antitumor necrosis factor antibody, in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy through 5 years in the GO-FORWARD trial.
  
  
  METHODS
  Patients with active RA despite MTX therapy were randomly assigned to receive placebo + MTX (Group 1), GOL 100 mg + placebo (Group 2), GOL 50 mg + MTX (Group 3), or GOL 100 mg + MTX (Group 4). Patients in groups 1, 2, and 3 with inadequate response could enter early escape at Week 16 to GOL 50 mg + MTX or GOL 100 mg + MTX, and all remaining Group 1 patients crossed over to GOL 50 mg + MTX at Week 24. The blind was maintained through the 52-week database lock, after which treatment adjustments were permitted. Adverse events (AE) were monitored through Week 268. Efficacy was evaluated using the American College of Rheumatology (ACR) 20/50/70 responses and a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). Response rates at Week 256 were analyzed by an intent-to-treat analysis.
  
  
  RESULTS
  A total of 444 patients were randomized, and 313 received GOL through Week 252; 301 patients completed the safety followup through Week 268. Infections were the most common type of AE; 172 patients (39.6%) had ≥ 1 serious AE. No unexpected safety signals were observed. At Week 256, ACR20/50/70 responses were achieved by 63.1%, 40.8%, and 24.1%, respectively, of all randomized patients. About 78% of all patients achieved a good or moderate DAS28-CRP response.
  
  
  CONCLUSIONS
  Improvements in the signs and symptoms of RA were maintained through 5 years. AE through 5 years were consistent with earlier reports of the GO-FORWARD trial; no apparent increased risk was observed over time.
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine. edkeystone@mtsinai.on.ca.
authors.forename: Edward C
authors.initials: EC
authors.lastname: Keystone
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hall
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Gathany
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Stephen
authors.initials: S
authors.lastname: Xu
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Yiying
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Jocelyn H
authors.initials: JH
authors.lastname: Leu
authors.affiliation: From Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Immunology and Rheumatology, Stanford University, Palo Alto, California; Janssen Global Services LLC, Malvern, Pennsylvania, USA; Biostatistics, Janssen Research & Development LLC, Malvern; Biologics Clinical Pharmacology, and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; Rheumatology, Cabrini Medical Centre, Malvern, Australia; Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.E.C. Keystone, MD, FRCP(C), Immunology and Rheumatology, University of Toronto and Mount Sinai Hospital; M.C. Genovese, MD, Immunology and Rheumatology, Stanford University; S. Hall, MBBS, FRACP, Rheumatology, Cabrini Medical Centre; S.C. Bae, MD, PhD, MPH, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases; C. Han, PhD, Janssen Global Services LLC; T.A. Gathany, MEd, Janssen Global Services LLC; S. Xu, MS, Biostatistics, Janssen Research & Development LLC; Y. Zhou, PhD, Biostatistics, Janssen Research & Development LLC; J.H. Leu, PhD, Biologics Clinical Pharmacology, Janssen Research & Development LLC; E.C. Hsia, MD, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania School of Medicine.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
mesh_terms: 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 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007279:Injections, Subcutaneous; D008727:Methotrexate / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate
keywords: BIOLOGICS; GOLIMUMAB; LONGTERM; RHEUMATOID ARTHRITIS