title: Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.
abstract: To evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).
  
  
  
  In the GO-BEFORE study, 637 MTX-naive adult patients with active RA were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week 28 to golimumab 50 mg + MTX, golimumab 100 mg + MTX, or golimumab 100 mg + MTX, respectively; remaining patients in group 1 could cross over to golimumab 50 mg + MTX at week 52. Assessments included the American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response, the Disease Activity Score in 28 joints (DAS28) using C-reactive protein (CRP) level, and the modified Sharp/van der Heijde score (SHS). Efficacy was analyzed using an intent-to-treat (ITT) analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.
  
  
  
  A total of 422 patients completed golimumab treatment through week 256. At week 256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n = 637) had an ACR20/50/70 response, respectively; 84.1% had a good or moderate DAS28-CRP response; and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week 256, and the overall mean change from baseline in SHS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week 256. Antibodies to golimumab occurred in 9.6% of patients through week 256. Infections were the most common type of adverse event (AE); 204 of 616 patients (33.1%) had ≥1 serious AE.
  
  
  
  Clinical efficacy with golimumab treatment was maintained through week 256 of the GO-BEFORE trial of MTX-naive RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports.
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Hospitals NHS Trust, Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: University of Texas and Southwest Medical Center, Dallas, Texas.
authors.forename: Roy M
authors.initials: RM
authors.lastname: Fleischmann
authors.affiliation: Instituto Reumatológico Strusberg, Córdoba, Argentina.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Strusberg
authors.affiliation: Service et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, and Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.affiliation: University of Queensland, Queensland, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Nash
authors.affiliation: University of the Philippines General Hospital, Manila, Philippines.
authors.forename: Eric Jason B
authors.initials: EJ
authors.lastname: Amante
authors.affiliation: Arthritis Center of Nebraska, Lincoln.
authors.forename: Melvin
authors.initials: M
authors.lastname: Churchill
authors.affiliation: Inha University Hospital, Incheon, South Korea.
authors.forename: Won
authors.initials: W
authors.lastname: Park
authors.affiliation: Sanatorio Parque, Santa Fe, Argentina.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Pons-Estel
authors.affiliation: Janssen Global Services, LLC, Malvern, Pennsylvania.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
authors.affiliation: Janssen Global Services, LLC, Malvern, Pennsylvania.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Gathany
authors.affiliation: Janssen Research & Development, Spring House, Pennsylvania.
authors.forename: Stephen
authors.initials: S
authors.lastname: Xu
authors.affiliation: Janssen Research & Development, Spring House, Pennsylvania.
authors.forename: Yiying
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Janssen Research & Development, Spring House, Pennsylvania.
authors.forename: Jocelyn H
authors.initials: JH
authors.lastname: Leu
authors.affiliation: Janssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania School of Medicine, Philadelphia.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate